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Completed

NCT Number: NCT00981617

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes Investigational Site, Tucson, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS33 (RDC-0313) (1 mg)

Drug

1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

ALKS33 (RDC-0313) (2.5 mg)

Drug

2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

ALKS33 (RDC-0313) (10 mg)

Drug

10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks

Placebo

Drug

Matching placebo taken once daily for 12 weeks

Primary outcomes

  1. Percent of subjects abstinent from heavy drinking

    Time frame: 12 Weeks

Secondary outcomes

  1. Percent of subjects abstinent from any drinking

    Time frame: 12 Weeks

  2. Percent of days abstinent from heavy drinking

    Time frame: 12 Weeks

  3. Percent of days abstinent from any alcohol

    Time frame: 12 Weeks

  4. Number of drinks per drinking day

    Time frame: 12 Weeks

  5. Days to relapse to first heavy drinking day

    Time frame: 12 Weeks

  6. Incidence of Adverse Events

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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