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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00981617
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: ALKS33 (RDC-0313) (1 mg) Drug: ALKS33 (RDC-0313) (2.5 mg) Drug: ALKS33 (RDC-0313) (10 mg) Drug: Placebo Phase 2

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Drug: ALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Experimental: ALKS33 (RDC-0313) (2.5 mg)
2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Drug: ALKS33 (RDC-0313) (2.5 mg)
2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Experimental: ALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Drug: ALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Placebo Comparator: Placebo
Matching placebo (capsules without active study drug) provided for daily oral administration
Drug: Placebo
Matching placebo taken once daily for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Percent of subjects abstinent from heavy drinking [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981617


  Show 27 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00981617     History of Changes
Other Study ID Numbers: ALK33-005
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
ALKS-33
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents