An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Placebo; Drug: Naltrexone; Drug: Naltrexone + Aripiprazole

• Registration Number: NCT00667875
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-28
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2016-03-17
• Results First Submitted QC: 2016-03-17
• Results First Posted: 2016-04-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Age 18 70

2. 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

3. 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)

4. 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

5. Able to read and understand questionnaires and informed consent

6. Lives within approximately 50 miles of the study site -

Exclusion Criteria

1. Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
2. Ever abused opiates
3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
4. 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
5. Meets DSM IV current criteria for dissociative disorder or eating disorders
6. Has current suicidal ideation or homicidal ideation
7. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
8. Current use of disulfiram
9. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
10. 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
11. 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
12. Has current charges pending for a violent crime (not including DUI-related offenses)
13. Does not have a stable living situation and a reliable source of collateral reporting
14. Has taken an opiate antagonist drug in the last month
15. Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Naltrexone	Naltrexone
3	Naltrexone + Aripiprazole	Naltrexone + Aripiprazole

Primary Outcome Measures

Name	Time	Method
Percent Heavy Drinking Days	16 weeks	percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)
Drinks Per Drinking Day	16-week treatment period	Standard drinks per drinking day

Secondary Outcome Measures

Name	Time	Method
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance	16 weeks treatment trial	Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime
Pill Counts During Treatment	16-week	Compliance with medication as determined by pill counts

Trial Locations

Locations (1)

Medical University of South Carolina, Center for Drug and Alcohol Programs; 🇺🇸 Charleston, South Carolina, United States