PTSDPhase 3NCT02884908
Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
A Phase 3 study testing Pregabalin plus BBCET in people with PTSD and Alcohol Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Alcohol Use Disorder
- What is being tested?
- Pregabalin plus BBCET
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 19 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of self-reported European or African American ancestry who have given written informed consent
- Age 18 to 65 years and weighing within 30% of their ideal body weight (Metropolitan Life Tables). Also, subjects must weigh at least 40 kg and no more than 155 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see exclusion criteria)
- Current Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) diagnosis of posttraumatic stress disorder (PTSD)
- Current DSM-5 diagnosis of alcohol use disorder (AUD) of moderate or greater severity (i.e., 4 or more AUD criteria endorsed) in the last 3 months
- Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men in the last 30 days and have met these criteria 7 days prior to randomization.
Show all 11Show fewer
- Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months
- The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
- Express a wish to stop drinking
- Willing to participate in behavioral treatments for PTSD and AUD
Who cannot join
- Any current DSM 5 psychiatric disorder other than PTSD, AUD, or Tobacco Use Disorder that warrants treatment or would preclude safe participation in the protocol
- Elevation of liver enzymes (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the upper limit of the normal range, or elevated bilirubin
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
- Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of topiramate
- Severe or life-threatening adverse reactions to medications in the past or during this clinical trial
- Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study
Show all 12Show fewer
- Received inpatient or outpatient treatment for alcohol dependence within the last 30 days
- Compelled to participate in an alcohol treatment program to maintain their liberty
- Members of the same household
- Active tuberculosis
- Concurrent treatment with any medications having a potential effect on alcohol consumption and related behaviors, or mood. These include: opioid antagonists (e.g., naltrexone), glutamate antagonists (e.g., topiramate or acamprosate), serotonin reuptake inhibitors (e.g., fluoxetine), serotonin antagonists (e.g., ritanserin or buspirone), other antidepressants (e.g., tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g., haloperidol), calcium channel antagonists (e.g., isradipine), or compounds with actions similar to disulfiram (Antabuse®) or nicotine.
- Before double-blind randomization, urine positive for opiates, cocaine, amphetamines, barbiturates, benzodiazepines, or prescription or non-prescription drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21228
About this study
The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a sample of African-Americans that includes both genders and individuals with different types of trauma.
Read the detailed description
Nearly 60% of individuals with posttraumatic stress disorder (PTSD) have a comorbid alcohol use disorder (AUD). This comorbidity is associated with more severe PTSD symptoms, higher rates of psychosocial and medical problems, higher relapse rates, and poorer treatment outcome. Pre-clinical studies have indicated that PTSD and AUD share common molecular underpinnings. Particularly, the adaptations in the brain neurotransmitter systems to chronic excessive drinking that are evident during alcohol withdrawal share similarities with PTSD cluster B and E symptoms (characterized by symptoms of re-experiencing and hyper-arousal), which initiate a cycle of relapse into excessive drinking and worsening of PTSD symptoms. Excessive glutamate and reduced gamma-amino butyric acid (GABA) neurotransmitter concentrations were found in various brain regions in individuals with co-morbid PTSD/AUD. The anticonvulsant pregabalin (with high affinity for the alpha-2-delta auxiliary site of voltage gated calcium channels) that modulates the effects of the GABA transporter (GAT-1) and increases its density of GABA, has shown preliminary efficacy in reducing drinking in AUD with comorbid generalized anxiety disorder, and improves outcomes from PTSD. Large scale studies with ample statistical power in VA settings and community populations, with diverse combat and non-combat related trauma, are now warranted to evaluate the promising preliminary evidence that pregabalin can improve outcomes for those with AUD and PTSD. An important personalized medicine approach to optimize pregabalin efficacy would be to select individuals with AUD and PTSD with genetic variation at the GAT-1 transporter so as to match its potential therapeutic effects with specific types of individual. In African-Americans, variants at the SLC6A1 gene promoter region insertion (i.e., non-insertion/insertion or insertion/insertion (NI/I or I/I) compared with those of Non-insertion/Non-insertion (NI/NI) type have significantly higher levels of GAT-1promoter activity. The investigators will, therefore, segregate our target sample by genetic variation at the GAT-1 transporter. Because of the low allelic frequency of individuals with the double copy insertion, the investigators will combine these into one group with those with the single copy (i.e., NI/I/II).
This study will test the efficacy of pregabalin in reducing both alcohol consumption and PTSD symptoms in 2 treatment groups of medication (pregabalin 450 mg/day and placebo) x 2 genetic variants (NI/I/II vs. NI/NI) in a double- blind, placebo-controlled 14-week clinical trial (screening, 12 weeks of study medication, follow-up call). After a one-week screening period, pregabalin dose (and placebo) will be titrated to the target dose from baseline to week 3 using a double-dummy procedure to ensure equivalence of capsules received. The investigators will utilize a sample of African-American participants with co-occurring AUD and PTSD that includes both genders and individuals with different types of trauma. Participants will receive standardized discussions to enhance compliance with study medication at all visits. The specific aims are:
Specific Aim 1: Independent of race, to test the hypothesis that AUD/PTSD participants treated with pregabalin will demonstrate a greater reduction in heavy drinking than placebo treated participants.
Specific Aim 2: Independent of race, to test the hypothesis that AUD/PTSD participants treated with pregabalin will demonstrate a greater reduction in PTSD cluster B or E symptoms (or both) than placebo-treated participants.
Specific Aim 3: To test the hypothesis that race will moderate the effects of pregabalin examined in Aims 1 and 2.
Specific Aim 4: To test the hypothesis that the treatment responses to pregabalin specified in Aims 1 and 2 are modulated by genetic variations within SLC6A1 gene in AUD/PTSD in both African American and European American populations.
- Conditions
- PTSD, Alcohol Use Disorder
- Being tested
- Pregabalin plus BBCET, Placebo plus BBCET
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin plus BBCETDrug
Also called Lyrica
Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment
Placebo plus BBCETOther
Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin + BBCET - NI/I/II type | Experimental | This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Receives: Drug: Pregabalin plus BBCET |
| Pregabalin + BBCET - NI/NI type | Experimental | This group will be comprised of subjects with the NI/NI type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Receives: Drug: Pregabalin plus BBCET |
| Placebo + BBCET - NI/I/II type | Placebo comparator | This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Receives: Other: Placebo plus BBCET |
| Placebo + BBCET - NI/NI type | Placebo comparator | This group will be comprised of subjects with the NI/NI type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Receives: Other: Placebo plus BBCET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB)
Heavy drinking days will be derived from the data collected by the TLFB interview for the last 7 days.
Measured: 12 weeks
PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL)
PTSD Cluster B symptoms assessed during treatment will be derived from the data collected with the PCL.
Measured: 12 weeks
PTSD Cluster E Symptoms as Measured by the PCL
PTSD Cluster E symptoms assessed during treatment will be derived from the data collected with the PCL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start7 Jul 2017
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Melanie E Bennett, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884908
- Sponsor's protocol ID
- 00069465
- Other IDs
- 5R01AA024760
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2016
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the NIH policy, and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, the investigators will provide all of our research resources available for research purposes to qualified individuals within the scientific community after publication of our results. Sharing of all of the research resources generated by this funded project will be in accordance with the federal rules or regulations imposed upon by the University of Maryland, Baltimore. The investigators will make the results available in accordance with the NIH Data Sharing policy. The investigators will analyze data and submit for peer reviewed publications in scientific journals. The investigators will also present the data in scientific meetings, symposia, or other scientific communications consistent with academic standards.
Publications
Baldwin DS, Anderson IM, Nutt DJ, Allgulander C, Bandelow B, den Boer JA, Christmas DM, Davies S, Fineberg N, Lidbetter N, Malizia A, McCrone P, Nabarro D, O'Neill C, Scott J, van der Wee N, Wittchen HU. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014 May;28(5):403-39. doi: 10.1177/0269881114525674. Epub 2014 Apr 8.
PubMed 24713617Baniasadi M, Hosseini G, Fayyazi Bordbar MR, Rezaei Ardani A, Mostafavi Toroghi H. Effect of pregabalin augmentation in treatment of patients with combat-related chronic posttraumatic stress disorder: a randomized controlled trial. J Psychiatr Pract. 2014 Nov;20(6):419-27. doi: 10.1097/01.pra.0000456590.12998.41.
PubMed 25406046Fowler M, Garza TH, Slater TM, Maani CV, McGhee LL. The relationship between gabapentin and pregabalin and posttraumatic stress disorder in burned servicemembers. J Burn Care Res. 2012 Sep-Oct;33(5):612-8. doi: 10.1097/BCR.0b013e31823dc710.
PubMed 22210072Guglielmo R, Martinotti G, Clerici M, Janiri L. Pregabalin for alcohol dependence: a critical review of the literature. Adv Ther. 2012 Nov;29(11):947-57. doi: 10.1007/s12325-012-0061-5. Epub 2012 Nov 5.
PubMed 23132700Johannessen Landmark C. Antiepileptic drugs in non-epilepsy disorders: relations between mechanisms of action and clinical efficacy. CNS Drugs. 2008;22(1):27-47. doi: 10.2165/00023210-200822010-00003.
PubMed 18072813Martinotti G. Pregabalin in clinical psychiatry and addiction: pros and cons. Expert Opin Investig Drugs. 2012 Sep;21(9):1243-5. doi: 10.1517/13543784.2012.703179. Epub 2012 Jun 24.
PubMed 22725618Martinotti G, Lupi M, Sarchione F, Santacroce R, Salone A, De Berardis D, Serroni N, Cavuto M, Signorelli M, Aguglia E, Valchera A, Iasevoli F, Di Giannantonio M. The potential of pregabalin in neurology, psychiatry and addiction: a qualitative overview. Curr Pharm Des. 2013;19(35):6367-74. doi: 10.2174/13816128113199990425.
PubMed 23782139Martinotti G, Di Nicola M, Tedeschi D, Andreoli S, Reina D, Pomponi M, Mazza M, Romanelli R, Moroni N, De Filippis R, Di Giannantonio M, Pozzi G, Bria P, Janiri L. Pregabalin versus naltrexone in alcohol dependence: a randomised, double-blind, comparison trial. J Psychopharmacol. 2010 Sep;24(9):1367-74. doi: 10.1177/0269881109102623. Epub 2009 Apr 3.
PubMed 19346279Mirijello A, Caputo F, Vassallo G, Rolland B, Tarli C, Gasbarrini A, Addolorato G. GABAB Agonists for the Treatment of Alcohol Use Disorder. Curr Pharm Des. 2015;21(23):3367-72. doi: 10.2174/1381612821666150619091858.
PubMed 26088121Oulis P, Konstantakopoulos G. Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence. Expert Opin Investig Drugs. 2012 Jul;21(7):1019-29. doi: 10.1517/13543784.2012.685651. Epub 2012 May 9.
PubMed 22568872Oulis P, Konstantakopoulos G. Pregabalin in the treatment of alcohol and benzodiazepines dependence. CNS Neurosci Ther. 2010 Spring;16(1):45-50. doi: 10.1111/j.1755-5949.2009.00120.x.
PubMed 20070788Pae CU, Marks DM, Han C, Masand PS, Patkar AA. Pregabalin augmentation of antidepressants in patients with accident-related posttraumatic stress disorder: an open label pilot study. Int Clin Psychopharmacol. 2009 Jan;24(1):29-33. doi: 10.1097/YIC.0b013e32831feea9.
PubMed 19060720Shorter D, Hsieh J, Kosten TR. Pharmacologic management of comorbid post-traumatic stress disorder and addictions. Am J Addict. 2015 Dec;24(8):705-12. doi: 10.1111/ajad.12306. Epub 2015 Nov 20.
PubMed 26587796Strawn JR, Dowling BP, Geracioti TD Jr. Pregabalin treatment of posttraumatic stress disorder. J Clin Psychopharmacol. 2008 Oct;28(5):596-7. doi: 10.1097/JCP.0b013e318184c8f2. No abstract available.
PubMed 18794673Wheeler PB, Mackey CD, Moskal D, Brady DJ, Foster KT, Marks RM, Dickerson DL, Kelly DL, Bennett ME, Roche DJO. Religiosity and the relationship between sexual trauma, alcohol use, and sleep quality: a moderated mediation model. Alcohol Alcohol. 2025 May 14;60(4):agaf030. doi: 10.1093/alcalc/agaf030.
PubMed 40483726
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
- ClinicalTrials.gov ID
- NCT02884908
- Acronym / sponsor ID
- 00069465
- Conditions
- PTSD, Alcohol Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a sample of African-Americans that includes both genders and individuals with different types of trauma.
Detailed description
Nearly 60% of individuals with posttraumatic stress disorder (PTSD) have a comorbid alcohol use disorder (AUD). This comorbidity is associated with more severe PTSD symptoms, higher rates of psychosocial and medical problems, higher relapse rates, and poorer treatment outcome. Pre-clinical studies have indicated that PTSD and AUD share common molecular underpinnings. Particularly, the adaptations in the brain neurotransmitter systems to chronic excessive drinking that are evident during alcohol withdrawal share similarities with PTSD cluster B and E symptoms (characterized by symptoms of re-experiencing and hyper-arousal), which initiate a cycle of relapse into excessive drinking and worsening of PTSD symptoms. Excessive glutamate and reduced gamma-amino butyric acid (GABA) neurotransmitter concentrations were found in various brain regions in individuals with co-morbid PTSD/AUD. The anticonvulsant pregabalin (with high affinity for the alpha-2-delta auxiliary site of voltage gated calcium channels) that modulates the effects of the GABA transporter (GAT-1) and increases its density of GABA, has shown preliminary efficacy in reducing drinking in AUD with comorbid generalized anxiety disorder, and improves outcomes from PTSD. Large scale studies with ample statistical power in VA settings and community populations, with diverse combat and non-combat related trauma, are now warranted to evaluate the promising preliminary evidence that pregabalin can improve outcomes for those with AUD and PTSD. An important personalized medicine approach to optimize pregabalin efficacy would be to select individuals with AUD and PTSD with genetic variation at the GAT-1 transporter so as to match its potential therapeutic effects with specific types of individual. In African-Americans, variants at the SLC6A1 gene promoter region insertion (i.e., non-insertion/insertion or insertion/insertion (NI/I or I/I) compared with those of Non-insertion/Non-insertion (NI/NI) type have significantly higher levels of GAT-1promoter activity. The investigators will, therefore, segregate our target sample by genetic variation at the GAT-1 transporter. Because of the low allelic frequency of individuals with the double copy insertion, the investigators will combine these into one group with those with the single copy (i.e., NI/I/II).
This study will test the efficacy of pregabalin in reducing both alcohol consumption and PTSD symptoms in 2 treatment groups of medication (pregabalin 450 mg/day and placebo) x 2 genetic variants (NI/I/II vs. NI/NI) in a double- blind, placebo-controlled 14-week clinical trial (screening, 12 weeks of study medication, follow-up call). After a one-week screening period, pregabalin dose (and placebo) will be titrated to the target dose from baseline to week 3 using a double-dummy procedure to ensure equivalence of capsules received. The investigators will utilize a sample of African-American participants with co-occurring AUD and PTSD that includes both genders and individuals with different types of trauma. Participants will receive standardized discussions to enhance compliance with study medication at all visits. The specific aims are:
Specific Aim 1: Independent of race, to test the hypothesis that AUD/PTSD participants treated with pregabalin will demonstrate a greater reduction in heavy drinking than placebo treated participants.
Specific Aim 2: Independent of race, to test the hypothesis that AUD/PTSD participants treated with pregabalin will demonstrate a greater reduction in PTSD cluster B or E symptoms (or both) than placebo-treated participants.
Specific Aim 3: To test the hypothesis that race will moderate the effects of pregabalin examined in Aims 1 and 2.
Specific Aim 4: To test the hypothesis that the treatment responses to pregabalin specified in Aims 1 and 2 are modulated by genetic variations within SLC6A1 gene in AUD/PTSD in both African American and European American populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin + BBCET - NI/I/II type | Experimental | Drug: Pregabalin plus BBCETThis group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). |
| Pregabalin + BBCET - NI/NI type | Experimental | Drug: Pregabalin plus BBCETThis group will be comprised of subjects with the NI/NI type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). |
| Placebo + BBCET - NI/I/II type | Placebo comparator | Other: Placebo plus BBCETThis group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). |
| Placebo + BBCET - NI/NI type | Placebo comparator | Other: Placebo plus BBCETThis group will be comprised of subjects with the NI/NI type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females of self-reported European or African American ancestry who have given written informed consent
- Age 18 to 65 years and weighing within 30% of their ideal body weight (Metropolitan Life Tables). Also, subjects must weigh at least 40 kg and no more than 155 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see exclusion criteria)
- Current Diagnostic and Statistical Manual of Mental Disorders Version 5 (DSM-5) diagnosis of posttraumatic stress disorder (PTSD)
- Current DSM-5 diagnosis of alcohol use disorder (AUD) of moderate or greater severity (i.e., 4 or more AUD criteria endorsed) in the last 3 months
Key exclusion criteria (12 listed)
- Any current DSM 5 psychiatric disorder other than PTSD, AUD, or Tobacco Use Disorder that warrants treatment or would preclude safe participation in the protocol
- Elevation of liver enzymes (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the upper limit of the normal range, or elevated bilirubin
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
- Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of topiramate
- Severe or life-threatening adverse reactions to medications in the past or during this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin plus BBCETAlso: LyricaMedication; BBCET = Brief Behavioral Compliance Enhancement Treatment | Drug | Pregabalin + BBCET - NI/I/II type, Pregabalin + BBCET - NI/NI type |
| Placebo plus BBCETPlacebo; BBCET = Brief Behavioral Compliance Enhancement Treatment | Other | Placebo + BBCET - NI/I/II type, Placebo + BBCET - NI/NI type |
Primary outcome
Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB)
Time frame: 12 weeks
Heavy drinking days will be derived from the data collected by the TLFB interview for the last 7 days.
PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL)
Time frame: 12 weeks
PTSD Cluster B symptoms assessed during treatment will be derived from the data collected with the PCL.
PTSD Cluster E Symptoms as Measured by the PCL
Time frame: 12 weeks
PTSD Cluster E symptoms assessed during treatment will be derived from the data collected with the PCL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24713617Baldwin DS, Anderson IM, Nutt DJ, Allgulander C, Bandelow B, den Boer JA, Christmas DM, Davies S, Fineberg N, Lidbetter N, Malizia A, McCrone P, Nabarro D, O'Neill C, Scott J, van der Wee N, Wittchen HU. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014 May;28(5):403-39. doi: 10.1177/0269881114525674. Epub 2014 Apr 8.
- Background: PubMed 25406046Baniasadi M, Hosseini G, Fayyazi Bordbar MR, Rezaei Ardani A, Mostafavi Toroghi H. Effect of pregabalin augmentation in treatment of patients with combat-related chronic posttraumatic stress disorder: a randomized controlled trial. J Psychiatr Pract. 2014 Nov;20(6):419-27. doi: 10.1097/01.pra.0000456590.12998.41.
- Background: PubMed 22210072Fowler M, Garza TH, Slater TM, Maani CV, McGhee LL. The relationship between gabapentin and pregabalin and posttraumatic stress disorder in burned servicemembers. J Burn Care Res. 2012 Sep-Oct;33(5):612-8. doi: 10.1097/BCR.0b013e31823dc710.
- Background: PubMed 23132700Guglielmo R, Martinotti G, Clerici M, Janiri L. Pregabalin for alcohol dependence: a critical review of the literature. Adv Ther. 2012 Nov;29(11):947-57. doi: 10.1007/s12325-012-0061-5. Epub 2012 Nov 5.
- Background: PubMed 18072813Johannessen Landmark C. Antiepileptic drugs in non-epilepsy disorders: relations between mechanisms of action and clinical efficacy. CNS Drugs. 2008;22(1):27-47. doi: 10.2165/00023210-200822010-00003.
- Background: PubMed 22725618Martinotti G. Pregabalin in clinical psychiatry and addiction: pros and cons. Expert Opin Investig Drugs. 2012 Sep;21(9):1243-5. doi: 10.1517/13543784.2012.703179. Epub 2012 Jun 24.
- Background: PubMed 23782139Martinotti G, Lupi M, Sarchione F, Santacroce R, Salone A, De Berardis D, Serroni N, Cavuto M, Signorelli M, Aguglia E, Valchera A, Iasevoli F, Di Giannantonio M. The potential of pregabalin in neurology, psychiatry and addiction: a qualitative overview. Curr Pharm Des. 2013;19(35):6367-74. doi: 10.2174/13816128113199990425.
- Background: PubMed 19346279Martinotti G, Di Nicola M, Tedeschi D, Andreoli S, Reina D, Pomponi M, Mazza M, Romanelli R, Moroni N, De Filippis R, Di Giannantonio M, Pozzi G, Bria P, Janiri L. Pregabalin versus naltrexone in alcohol dependence: a randomised, double-blind, comparison trial. J Psychopharmacol. 2010 Sep;24(9):1367-74. doi: 10.1177/0269881109102623. Epub 2009 Apr 3.
- Background: PubMed 26088121Mirijello A, Caputo F, Vassallo G, Rolland B, Tarli C, Gasbarrini A, Addolorato G. GABAB Agonists for the Treatment of Alcohol Use Disorder. Curr Pharm Des. 2015;21(23):3367-72. doi: 10.2174/1381612821666150619091858.
- Background: PubMed 22568872Oulis P, Konstantakopoulos G. Efficacy and safety of pregabalin in the treatment of alcohol and benzodiazepine dependence. Expert Opin Investig Drugs. 2012 Jul;21(7):1019-29. doi: 10.1517/13543784.2012.685651. Epub 2012 May 9.
- Background: PubMed 20070788Oulis P, Konstantakopoulos G. Pregabalin in the treatment of alcohol and benzodiazepines dependence. CNS Neurosci Ther. 2010 Spring;16(1):45-50. doi: 10.1111/j.1755-5949.2009.00120.x.
- Background: PubMed 19060720Pae CU, Marks DM, Han C, Masand PS, Patkar AA. Pregabalin augmentation of antidepressants in patients with accident-related posttraumatic stress disorder: an open label pilot study. Int Clin Psychopharmacol. 2009 Jan;24(1):29-33. doi: 10.1097/YIC.0b013e32831feea9.
- Individual participant dataSharing planned: Yes. Following the NIH policy, and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, the investigators will provide all of our research resources available for research purposes to qualified individuals within the scientific community after publication of our results. Sharing of all of the research resources generated by this funded project will be in accordance with the federal rules or regulations imposed upon by the University of Maryland, Baltimore. The investigators will make the results available in accordance with the NIH Data Sharing policy. The investigators will analyze data and submit for peer reviewed publications in scientific journals. The investigators will also present the data in scientific meetings, symposia, or other scientific communications consistent with academic standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin plus BBCET in people with PTSD and Alcohol Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884908, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.