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, Inc.
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, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981617

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

No publications provided

Responsible Party: Alkermes, Inc.
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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 21, 2014