An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Alcohol Dependence Clinical Trial

— NALAPZ  

Official title:

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667875
• Other study ID #: ANTON-1R21AA017525-01
• Secondary ID: R21AA017525NIH G
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2008
• Last updated: August 31, 2017
• Start date: April 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2017
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Placebo
placebo
• Naltrexone
Naltrexone (25mg or 50 mg per titration schedule)
• Naltrexone + Aripiprazole
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Center for Drug and Alcohol Programs	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinks Per Drinking Day	Standard drinks per drinking day	16-week treatment period
Primary	Percent Heavy Drinking Days	percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)	16 weeks
Secondary	Pill Counts During Treatment	Compliance with medication as determined by pill counts	16-week
Secondary	Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance	Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime	16 weeks treatment trial