Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2009-07-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pregabalin for Alcohol Dependence
NCT02205879
Pregabalin Trial for the Treatment of Alcohol Use Disorder
NCT04322305
Pregabalin as Treatment for Alcohol Use Disorder
NCT03256253
Gabapentin Treatment of Alcohol Dependence
NCT00391716
Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
NCT02884908
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duloxetine
Duloxetine
40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Pregabalin
Pregabalin
Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Placebo
Placebo
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pregabalin
Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Duloxetine
40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Placebo
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
* Seeking research-based outpatient treatment for alcohol problems
* Willing to attend 12 weekly study visits and 2 follow-up visits
* Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency
Exclusion Criteria
* Medical disorders that will increase potential risk or interfere with study participation
* Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
* Males who refuse to use a reliable method of birth control
* Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.
* Inability to understand and/or comply with the provisions of the protocol and consent form
* Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization
* Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain
* Ongoing treatment with drugs that may increase potential risk (Actos),
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
The Scripps Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barbara J. Mason
PI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barbara J Mason, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Scripps Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Study Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MERIT
Identifier Type: -
Identifier Source: secondary_id
AA014028
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.