Alcohol Dependence Clinical Trial
Official title:
Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation, During Cue Induced Brain Imaging, and During a Motivated Free Choice Drinking Procedure Compared to Placebo
The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be
recruited through advertisement and paid for their participation. Alcoholics, after baseline
evaluation, will be assigned through urn randomization to one of two experimental groups in
which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo.
Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural
observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they
will undergo an alcohol administration (priming dose) and motivated free choice drinking
procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end
of the study to enhance their awareness of problem drinking and to motivate them to seek
treatment. Referral for treatment will be offered.
Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the
evening before the alcohol administration paradigm. fMRI brain imaging technology will be
used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced
activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus
accumbens activation to alcohol cues compared to placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03340051 -
Remote Alcohol Monitoring and Episodic Thinking
|
N/A | |
| Completed |
NCT02901041 -
Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
|
Phase 3 | |
| Not yet recruiting |
NCT06444243 -
Psilocybin-assisted Therapy for Alcohol Use Disorder
|
Phase 2 | |
| Completed |
NCT02486900 -
Neurofeedback & Alcohol Dependence
|
N/A | |
| Completed |
NCT02705898 -
Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
|
N/A | |
| Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
| Completed |
NCT02197598 -
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
|
Phase 4 | |
| Recruiting |
NCT02385643 -
The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
|
N/A | |
| Completed |
NCT01828866 -
Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients
|
N/A | |
| Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
| Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
| Completed |
NCT01342549 -
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
|
Phase 3 | |
| Completed |
NCT02193204 -
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
|
N/A | |
| Completed |
NCT01176591 -
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
|
Phase 2 | |
| Completed |
NCT01165541 -
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
|
Phase 2 | |
| Completed |
NCT00585780 -
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
|
Phase 1/Phase 2 | |
| Completed |
NCT01056484 -
Mindfulness Meditation for Health
|
Phase 2 | |
| Completed |
NCT00607620 -
Disseminating Organizational SBI Services at Trauma Centers
|
N/A | |
| Completed |
NCT00884884 -
Aripiprazole and Topiramate on Free-Choice Alcohol Use
|
Phase 2/Phase 3 | |
| Completed |
NCT00463346 -
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
|
Phase 3 |