ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: ALKS-33

Criteria

Inclusion Criteria:

• 18 years of age or older

• Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women)

• A noncustodial stable residence and a telephone

• Women having reproductive potential must agree to use an approved method of contraception for the duration of the study

• Ability to stop drinking prior to receiving study drug

Exclusion Criteria:

• Pregnancy and/or current breastfeeding

• Past or present history of an AIDS-indicator disease

• Current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol)

• Positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at Visits 1 and 2

• Clinically significant medical condition

• Current or anticipated need for prescribed opioid medication during the study period

• Use of naltrexone within 60 days prior to screening

• Current need for antidepressants (within 30 days prior to entry)

• Participation in a clinical trial of a pharmacological agent within 30 days prior to screening

• Parole or probation or pending legal proceedings that have the potential for incarceration during the study period