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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT00981617
First received: September 21, 2009
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Percent of subjects abstinent from heavy drinking [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of subjects abstinent from any drinking [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percent of days abstinent from heavy drinking [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percent of days abstinent from any alcohol [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Number of drinks per drinking day [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Days to relapse to first heavy drinking day [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 406
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981617

  Show 27 Study Locations
Sponsors and Collaborators
Alkermes
  More Information

No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT00981617     History of Changes
Other Study ID Numbers: ALK33-005
Study First Received: September 21, 2009
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014