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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multi-center, randomized, double-blind, placebo-controlled study. A 3-stage adaptive design will be used. Following screening, eligible subjects will be randomized equally to 1 of 4 groups (ALKS33 [RDC-0313] [1, 2.5, OR 10 mg], or matching placebo).

Official Title
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A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Adaptive Study of the Safety and Efficacy of RDC-0313 in Adults With Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: ALKS33 (RDC-0313) (1 mg)
* Drug: ALKS33 (RDC-0313) (2.5 mg)
* Drug: ALKS33 (RDC-0313) (10 mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS33 (RDC-0313) (1 mg)<br>1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration | Drug: ALKS33 (RDC-0313) (1 mg)<br>* 1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks<br>|
| Experimental: ALKS33 (RDC-0313) (2.5 mg)<br>2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration | Drug: ALKS33 (RDC-0313) (2.5 mg)<br>* 2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks<br>|
| Experimental: ALKS33 (RDC-0313) (10 mg)<br>10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration | Drug: ALKS33 (RDC-0313) (10 mg)<br>* 10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Matching placebo (capsules without active study drug) provided for daily oral administration | Drug: Placebo<br>* Matching placebo taken once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects abstinent from heavy drinking |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects abstinent from any drinking |  | 12 Weeks | 
| Percent of days abstinent from heavy drinking |  | 12 Weeks | 
| Percent of days abstinent from any alcohol |  | 12 Weeks | 
| Number of drinks per drinking day |  | 12 Weeks | 
| Days to relapse to first heavy drinking day |  | 12 Weeks | 
| Incidence of Adverse Events |  | 12 Weeks |