An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence (NALAPZ)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Placebo Drug: Naltrexone Drug: Naltrexone + Aripiprazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence |
- drinks per drinking day [ Time Frame: 16-week treatment period ] [ Designated as safety issue: No ]
- Pill counts and urinary riboflavin levels during treatment [ Time Frame: 16-week ] [ Designated as safety issue: No ]
- Subject-reported adverse events on the SAFTEE interview [ Time Frame: 16-week ] [ Designated as safety issue: Yes ]
- Percent heavy drinking days over the 16-week study [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
placebo
|
|
Active Comparator: 2
Naltrexone
|
Drug: Naltrexone
Naltrexone (25mg or 50 mg per titration schedule)
|
|
Active Comparator: 3
Naltrexone + Aripiprazole
|
Drug: Naltrexone + Aripiprazole
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 70
Subjects will meet criteria for primary alcohol dependence operationalized as follows:
A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification
- Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
- Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
- Able to read and understand questionnaires and informed consent
- Lives within approximately 50 miles of the study site -
Exclusion Criteria:
- Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
- Ever abused opiates
- Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
- Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
- Meets DSM IV current criteria for dissociative disorder or eating disorders
- Has current suicidal ideation or homicidal ideation
- Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
- Current use of disulfiram
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
- Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
- Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not using a reliable form of birth control
- Has current charges pending for a violent crime (not including DUI-related offenses)
- Does not have a stable living situation and a reliable source of collateral reporting
- Has taken an opiate antagonist drug in the last month
- Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
Contacts and Locations| United States, South Carolina | |
| Medical University of South Carolina, Center for Drug and Alcohol Programs | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Raymond F Anton, M.D. | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Raymond F. Anton, M.D., Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00667875 History of Changes |
| Other Study ID Numbers: | ANTON-1R21AA017525-01, R21AA017525, NIH Grant AA017525-01 |
| Study First Received: | April 24, 2008 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Medical University of South Carolina:
|
Alcohol Dependence Alcoholism Naltrexone Aripiprazole Substance Abuse |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Aripiprazole Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013