AlcoholismPhase 2TOPGNCT02371889
A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers
A Phase 2 study testing Topiramate and Medical Management in people with Alcoholism and Alcohol Use Disorder (AUD), run by University of Pennsylvania at 2 sites in United States.
Trial summary
The purpose of this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholism, Alcohol Use Disorder (AUD)
- What is being tested?
- Topiramate and Medical Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2014to Feb 2020
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Determined to be physically healthy, based on medical history and physical examination and approval of the study physician
- Age 18 to 70 years, inclusive
- Self-identified European ancestry
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of >24 standard drinks for men and >18 standard drinks for women, with a weekly average of > 2 HDDs during the month before screening
- Stated goal to reduce drinking to safe levels or to stop drinking
Show all 10Show fewer
- Able to read English at an 8th grade or higher level and no gross cognitive impairment
- Willingness to nominate an individual who will know the subject's whereabouts to facilitate follow up during the study
- Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or is less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth control, and have a negative urine pregnancy test prior to the initiation of treatment. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
Who cannot join
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal
- A history of nephrolithiasis
- A history of glaucoma
- Current treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis.
- Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder, or imminent suicide or violence risk)
- Current DSM-IV diagnosis of dependence on a drug other than alcohol or nicotine
Show all 12Show fewer
- A history of hypersensitivity to topiramate
- Current regular treatment with a psychotropic medication (e.g., benzodiazepines, antidepressants), which affect neurotransmitter systems, or a medication to treat alcohol dependence
- Currently taking any tricyclic antidepressant (e.g., Adapin (doxepin), Anafranil (clomipramine), Elavil (amitryptyline), Pamelor (nortryptyline), Tofranil (imipramine), Sinequan (doxepin)
- Urine drug screen positive for recent use of opioids, cocaine, or amphetamines (may be repeated once and if the result is negative on repeat it is not exclusionary)
- Because co-administration of topiramate with dolutegravir reduced plasma concentrations of the antiretroviral through induction of CYP3A, the use of dolutegravir is exclusionary.
- Judged by the principal investigator or his designee to be an unsuitable candidate for receipt of an investigational drug
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in the four medication x genotype groups. The investigators will use daily data collection to examine changes in relevant process variables (e.g., alcohol expectancies) and their interaction with genotype and medication group as predictors of HD. The proposed study is innovative in that it will be the first prospective test of a pharmacogenetic hypothesis involving TOP; it will use daily reports to examine expectancies and how they interact with medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is either to reduce or stop drinking, which will increase the study's external validity.
Read the detailed description
This is a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of topiramate in reducing HD in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most topiramate-responsive genotype, to ensure comparable numbers of subjects in the four medication x genotype groups. The investigators will compare the efficacy of topiramate to placebo in reducing the frequency of HDDs in subjects with AUD using a two-arm, parallel-groups design. Subjects will either have a goal of reducing their drinking to safe levels or abstinence.
The investigators will use daily data collection to examine changes in relevant process variables and their interaction with genotype and medication group as predictors of HD. At each visit, all subjects will receive Medication Management (Pettinati, Weiss et al. 2004), which was developed for the COMBINE Trial and which the investigators modified to be relevant for both reducing heavy drinking and promoting abstinence. Random assignment to treatment group and double-blind conditions will be maintained throughout the study. Raters will be trained in the reliable use of all assessments. The investigators will use serum GGTP and percent disialotransferrin (%dCDT), an improved assay for carbohydrate deficient transferrin, to validate subject reports. Following a one-week pre-treatment assessment period, subjects will receive 12 weeks of treatment, after which there will be a 6-day taper period, during which subjects will reduce their dosage of topiramate gradually and then discontinue it completely. Daily reports during the treatment period will be obtained using interactive voice response (IVR) to identify subjective correlates of medication effects and to monitor medication use. Following the 12-week treatment period, subjects will be asked to return to the clinic for 3-month and 6-month post-treatment follow-up visits to evaluate the durability of treatment effects.
Two hundred men and women of European descent will be randomized to study medication. Subjects will be recruited using referrals from treatment programs throughout Philadelphia; IRB-approved advertisements on mass transit, on local radio and television stations and in newspapers, social media, and broadcast email messages at institutions that offer such a service and by posting/distributing recruitment materials in community and college settings. Respondents will initially be evaluated by telephone prior to an in-person visit to the Treatment Research Center of the University of Pennsylvania Perelman School of Medicine. The investigators will select subjects based on their genotype to ensure comparable numbers of individuals who are rs2832407*C-allele homozygotes and A-allele carriers. The investigators will block randomize subjects to balance the groups on treatment goal (i.e., reduced drinking or abstinence).
- Conditions
- Alcoholism, Alcohol Use Disorder (AUD)
- Being tested
- Topiramate, Medical Management, Inactive Placebo
- Keywords
- Topiramate, Pharmacogenetics, Personalized Medicine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Max therapeutic dose of 200mg/day
Medical ManagementBehavioural
Also called MM
Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The subject is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
Inactive PlaceboDrug
In capsules indistinguishable from topiramate capsules and gradually increased to a maximum equivalent of 200 mg of topiramate/day
| Study group | Role | What they receive |
|---|---|---|
| Topiramate + Medical Management | Experimental | Topiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit Receives: Drug: Topiramate; Behavioral: Medical Management |
| Placebo Pill + Medical Management | Placebo comparator | Inactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit Receives: Behavioral: Medical Management; Drug: Inactive Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Heavy Drinking Days by Medication Group (Timeline Follow Back Calendar).
The number of Heavy Drinking Days during 12 weeks of treatment in the topiramate and placebo groups.
Measured: 12 weeks
Frequency of Heavy Drinking Days Per Day by Medication and Genotype Group (Timeline Follow Back Calendar).
Number of Heavy Drinking Days in the last week of the 12 week treatment phase by medication group and rs2832407 genotype group.
Measured: 12 weeks
Numbers of Drinking Days Over 12 Weeks Treatment by Medication Group.
Numbers of drinking days over 12 week treatment phase by medication group. Data was collected using timeline follow back calendar.
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 posted26 Feb 2015 (estimated)
- Study start18 Dec 2014
- Primary completionFeb 2020
- Study completionFeb 2020
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 (3)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Department of Health and Human Services, Corporal Michael J. Crescenz VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Henry R Kranzler, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371889
- Sponsor's protocol ID
- 821035
- Other IDs
- 821035, R01AA023192
- Acronym
- TOPG
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2015
- Last updated
- 20 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kranzler HR, Jinwala Z, Davis CN, Xu H, Biernacka JM, Zhou H, Kember RL, Gelernter J, Feinn R. Moderation of treatment outcomes by polygenic risk for alcohol-related traits in placebo-controlled trials of topiramate. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1297-1305. doi: 10.1111/acer.70052. Epub 2025 May 30.
PubMed 40445294Kranzler HR, Feinn R, Pond T, Hartwell E, Gelernter J, Crist RC, Witkiewitz K. Post-treatment effects of topiramate on alcohol-related outcomes: A combined analysis of two placebo-controlled trials. Addict Biol. 2022 Mar;27(2):e13130. doi: 10.1111/adb.13130.
PubMed 35229945Kranzler HR, Hartwell EE, Feinn R, Pond T, Witkiewitz K, Gelernter J, Crist RC. Combined analysis of the moderating effect of a GRIK1 polymorphism on the effects of topiramate for treating alcohol use disorder. Drug Alcohol Depend. 2021 Aug 1;225:108762. doi: 10.1016/j.drugalcdep.2021.108762. Epub 2021 May 21.
PubMed 34049101
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers
- ClinicalTrials.gov ID
- NCT02371889
- Acronym / sponsor ID
- TOPG / 821035
- Conditions
- Alcoholism, Alcohol Use Disorder (AUD)
- Keywords
- Topiramate, Pharmacogenetics, Personalized Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Department of Health and Human Services, Corporal Michael J. Crescenz VA Medical Center
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 21 Feb 2021
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 this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in the four medication x genotype groups. The investigators will use daily data collection to examine changes in relevant process variables (e.g., alcohol expectancies) and their interaction with genotype and medication group as predictors of HD. The proposed study is innovative in that it will be the first prospective test of a pharmacogenetic hypothesis involving TOP; it will use daily reports to examine expectancies and how they interact with medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is either to reduce or stop drinking, which will increase the study's external validity.
Detailed description
This is a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of topiramate in reducing HD in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most topiramate-responsive genotype, to ensure comparable numbers of subjects in the four medication x genotype groups. The investigators will compare the efficacy of topiramate to placebo in reducing the frequency of HDDs in subjects with AUD using a two-arm, parallel-groups design. Subjects will either have a goal of reducing their drinking to safe levels or abstinence.
The investigators will use daily data collection to examine changes in relevant process variables and their interaction with genotype and medication group as predictors of HD. At each visit, all subjects will receive Medication Management (Pettinati, Weiss et al. 2004), which was developed for the COMBINE Trial and which the investigators modified to be relevant for both reducing heavy drinking and promoting abstinence. Random assignment to treatment group and double-blind conditions will be maintained throughout the study. Raters will be trained in the reliable use of all assessments. The investigators will use serum GGTP and percent disialotransferrin (%dCDT), an improved assay for carbohydrate deficient transferrin, to validate subject reports. Following a one-week pre-treatment assessment period, subjects will receive 12 weeks of treatment, after which there will be a 6-day taper period, during which subjects will reduce their dosage of topiramate gradually and then discontinue it completely. Daily reports during the treatment period will be obtained using interactive voice response (IVR) to identify subjective correlates of medication effects and to monitor medication use. Following the 12-week treatment period, subjects will be asked to return to the clinic for 3-month and 6-month post-treatment follow-up visits to evaluate the durability of treatment effects.
Two hundred men and women of European descent will be randomized to study medication. Subjects will be recruited using referrals from treatment programs throughout Philadelphia; IRB-approved advertisements on mass transit, on local radio and television stations and in newspapers, social media, and broadcast email messages at institutions that offer such a service and by posting/distributing recruitment materials in community and college settings. Respondents will initially be evaluated by telephone prior to an in-person visit to the Treatment Research Center of the University of Pennsylvania Perelman School of Medicine. The investigators will select subjects based on their genotype to ensure comparable numbers of individuals who are rs2832407*C-allele homozygotes and A-allele carriers. The investigators will block randomize subjects to balance the groups on treatment goal (i.e., reduced drinking or abstinence).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate + Medical Management | Experimental | Drug: Topiramate, Behavioral: Medical ManagementTopiramate 200 mg/day orally in two divided doses. Dose will be titrated upward over a six-week period, maintained for 6 weeks, then tapered over 6 days + Medical Management sessions for 15-25 minutes per study visit |
| Placebo Pill + Medical Management | Placebo comparator | Behavioral: Medical Management, Drug: Inactive PlaceboInactive placebo with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Determined to be physically healthy, based on medical history and physical examination and approval of the study physician
- Age 18 to 70 years, inclusive
- Self-identified European ancestry
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of >24 standard drinks for men and >18 standard drinks for women, with a weekly average of > 2 HDDs during the month before screening
Key exclusion criteria (12 listed)
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal
- A history of nephrolithiasis
- A history of glaucoma
- Current treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis.
- Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder, or imminent suicide or violence risk)
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 |
|---|---|---|
| TopiramateAlso: TopamaxMax therapeutic dose of 200mg/day | Drug | Topiramate + Medical Management |
| Medical ManagementAlso: MMMedical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The subject is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week. | Behavioural | Placebo Pill + Medical Management, Topiramate + Medical Management |
| Inactive PlaceboIn capsules indistinguishable from topiramate capsules and gradually increased to a maximum equivalent of 200 mg of topiramate/day | Drug | Placebo Pill + Medical Management |
Primary outcome
Frequency of Heavy Drinking Days by Medication Group (Timeline Follow Back Calendar).
Time frame: 12 weeks
The number of Heavy Drinking Days during 12 weeks of treatment in the topiramate and placebo groups.
Frequency of Heavy Drinking Days Per Day by Medication and Genotype Group (Timeline Follow Back Calendar).
Time frame: 12 weeks
Number of Heavy Drinking Days in the last week of the 12 week treatment phase by medication group and rs2832407 genotype group.
Numbers of Drinking Days Over 12 Weeks Treatment by Medication Group.
Time frame: 12 weeks
Numbers of drinking days over 12 week treatment phase by medication group. Data was collected using timeline follow back calendar.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40445294Kranzler HR, Jinwala Z, Davis CN, Xu H, Biernacka JM, Zhou H, Kember RL, Gelernter J, Feinn R. Moderation of treatment outcomes by polygenic risk for alcohol-related traits in placebo-controlled trials of topiramate. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1297-1305. doi: 10.1111/acer.70052. Epub 2025 May 30.
- Derived from this study: PubMed 35229945Kranzler HR, Feinn R, Pond T, Hartwell E, Gelernter J, Crist RC, Witkiewitz K. Post-treatment effects of topiramate on alcohol-related outcomes: A combined analysis of two placebo-controlled trials. Addict Biol. 2022 Mar;27(2):e13130. doi: 10.1111/adb.13130.
- Derived from this study: PubMed 34049101Kranzler HR, Hartwell EE, Feinn R, Pond T, Witkiewitz K, Gelernter J, Crist RC. Combined analysis of the moderating effect of a GRIK1 polymorphism on the effects of topiramate for treating alcohol use disorder. Drug Alcohol Depend. 2021 Aug 1;225:108762. doi: 10.1016/j.drugalcdep.2021.108762. Epub 2021 May 21.
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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.
Henry R Kranzler, M.D. principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topiramate and Medical Management in people with Alcoholism and Alcohol Use Disorder (AUD), run by University of Pennsylvania at 2 sites 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 10 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Feb 2021). 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?
Frequency of Heavy Drinking Days by Medication Group (Timeline Follow Back Calendar). (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 NCT02371889, which also lists 3 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 20 Jan 2022.