Alcohol Use DisordersNCT02226367
Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
A study testing prazosin hydrochloride in people with Alcohol Use Disorders and Stress Disorders, Posttraumatic, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
The purpose of the study is to evaluate if the drug prazosin: will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and determine if presence or absence of posttraumatic stress disorder affects treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorders, Stress Disorders, Posttraumatic, Combat Disorders
- What is being tested?
- prazosin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 20 Oct 2018
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder
- Participant in Army Substance Abuse Program (6 or 12 week program)
- Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men)
- Good general medical health (see Exclusion Criteria below)
- Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study.
- Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to Baseline
- Capacity to provide informed consent
- English fluency
Who cannot join
- Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal substance dependence or abuse.
- Signs or symptoms of alcohol withdrawal at the time of initial consent
- Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar disorder, or cognitive disorder.
- Suicide attempt or suicidal ideation with intent in the past month.
- Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <100) or orthostatic hypotension (defined as a systolic drop > 20 mmHg after two minutes standing accompanied by lightheadedness or syncope); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's disease. Liver function tests more than 5 times the upper limit.
- Concomitant use of trazodone (due to increased risk of priapism). There will be a two week trazodone washout period before the baseline visit.
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- Concomitant use of an alpha-1 blocker medication or insulin
- Use of prazosin in the 4 weeks prior to Baseline.
- History of prazosin sensitivity/allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
The purpose of the study is to evaluate if the drug prazosin:
- will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and
- determine if presence or absence of posttraumatic stress disorder affects treatment.
Read the detailed description
The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.
- Being tested
- prazosin hydrochloride, placebo
- Keywords
- prazosin, alcohol use disorders, posttraumatic stress disorder, PTSD, combat trauma, military, alpha-1 adrenoreceptor antagonist
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prazosin hydrochlorideDrug
Also called prazosin, Pfizer Minipress
study drug arm prazosin
placeboDrug
Also called sugar pill
study drug arm placebo
| Study group | Role | What they receive |
|---|---|---|
| prazosin hydrochloride | Active comparator | Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. Receives: Drug: prazosin hydrochloride |
| placebo | Placebo comparator | Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Penn Alcohol Craving Scale Score
Penn Alcohol Craving Scale (PACS)
The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.
Measured: Change at Week 13 from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJan 2015
- Primary completion20 Sep 2018
- Study completion20 Oct 2018
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.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, VA Puget Sound Health Care System
- Responsible party
- Sponsor
- Investigators
- Murray Raskind, MD, Principal investigator, Department of Veterans Affairs Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226367
- Sponsor's protocol ID
- W81XWH-12-2-0094
- Status last verified
- Jan 2023
- First submitted
- 15 Jul 2014
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
- ClinicalTrials.gov ID
- NCT02226367
- Acronym / sponsor ID
- W81XWH-12-2-0094
- Keywords
- prazosin, alcohol use disorders, posttraumatic stress disorder, PTSD, combat trauma, military, alpha-1 adrenoreceptor antagonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense, VA Puget Sound Health Care System
- Study start
- Jan 2015
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate if the drug prazosin:
- will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and
- determine if presence or absence of posttraumatic stress disorder affects treatment.
Detailed description
The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prazosin hydrochloride | Active comparator | Drug: prazosin hydrochloridePrazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. |
| placebo | Placebo comparator | Drug: placeboPlacebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder
- Participant in Army Substance Abuse Program (6 or 12 week program)
- Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men)
- Good general medical health (see Exclusion Criteria below)
- Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study.
Key exclusion criteria (9 listed)
- Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal substance dependence or abuse.
- Signs or symptoms of alcohol withdrawal at the time of initial consent
- Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar disorder, or cognitive disorder.
- Suicide attempt or suicidal ideation with intent in the past month.
- Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <100) or orthostatic hypotension (defined as a systolic drop > 20 mmHg after two minutes standing accompanied by lightheadedness or syncope); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's disease. Liver function tests more than 5 times the upper limit.
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 |
|---|---|---|
| prazosin hydrochlorideAlso: prazosin, Pfizer Minipressstudy drug arm prazosin | Drug | prazosin hydrochloride |
| placeboAlso: sugar pillstudy drug arm placebo | Drug | placebo |
Primary outcome
Change in Penn Alcohol Craving Scale Score
Time frame: Change at Week 13 from Baseline
Penn Alcohol Craving Scale (PACS) The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Murray Raskind, MD principal investigator
Department of Veterans Affairs Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prazosin hydrochloride in people with Alcohol Use Disorders and Stress Disorders, Posttraumatic, run by Seattle Institute for Biomedical and Clinical Research 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 8 inclusion and 9 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 3 Feb 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). 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?
Change in Penn Alcohol Craving Scale Score (time frame: Change at Week 13 from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023.