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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2010

Detailed Description

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).

Interventions

  • Drug: ALKS33 (RDC-0313) (1 mg)
    • 1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
  • Drug: ALKS33 (RDC-0313) (2.5 mg)
    • 2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
  • Drug: ALKS33 (RDC-0313) (10 mg)
    • 10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
  • Drug: Placebo
    • Matching placebo taken once daily for 12 weeks

Arms, Groups and Cohorts

  • Experimental: ALKS33 (RDC-0313) (1 mg)
    • 1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
  • Experimental: ALKS33 (RDC-0313) (2.5 mg)
    • 2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
  • Experimental: ALKS33 (RDC-0313) (10 mg)
    • 10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
  • Placebo Comparator: Placebo
    • Matching placebo (capsules without active study drug) provided for daily oral administration

Clinical Trial Outcome Measures

Primary Measures

  • Percent of subjects abstinent from heavy drinking
    • Time Frame: 12 Weeks

Secondary Measures

  • Percent of subjects abstinent from any drinking
    • Time Frame: 12 Weeks
  • Percent of days abstinent from heavy drinking
    • Time Frame: 12 Weeks
  • Percent of days abstinent from any alcohol
    • Time Frame: 12 Weeks
  • Number of drinks per drinking day
    • Time Frame: 12 Weeks
  • Days to relapse to first heavy drinking day
    • Time Frame: 12 Weeks
  • Incidence of Adverse Events
    • Time Frame: 12 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alkermes, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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