Back to resultsALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALKS33 (RDC-0313) (1 mg)
ALKS33 (RDC-0313) (2.5 mg)
ALKS33 (RDC-0313) (10 mg)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility 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
Sites / Locations
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
- Alkermes Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ALKS33 (RDC-0313) (1 mg)
ALKS33 (RDC-0313) (2.5 mg)
ALKS33 (RDC-0313) (10 mg)
Placebo
Arm Description
1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Matching placebo (capsules without active study drug) provided for daily oral administration
Outcomes
Primary Outcome Measures
Percent of subjects abstinent from heavy drinking
Secondary Outcome Measures
Percent of subjects abstinent from any drinking
Percent of days abstinent from heavy drinking
Percent of days abstinent from any alcohol
Number of drinks per drinking day
Days to relapse to first heavy drinking day
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00981617
Brief Title
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALKS33 (RDC-0313) (1 mg)
Arm Type
Experimental
Arm Description
1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Arm Title
ALKS33 (RDC-0313) (2.5 mg)
Arm Type
Experimental
Arm Description
2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Arm Title
ALKS33 (RDC-0313) (10 mg)
Arm Type
Experimental
Arm Description
10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo (capsules without active study drug) provided for daily oral administration
Intervention Type
Drug
Intervention Name(s)
ALKS33 (RDC-0313) (1 mg)
Intervention Description
1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ALKS33 (RDC-0313) (2.5 mg)
Intervention Description
2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ALKS33 (RDC-0313) (10 mg)
Intervention Description
10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo taken once daily for 12 weeks
Primary Outcome Measure Information:
Title
Percent of subjects abstinent from heavy drinking
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Percent of subjects abstinent from any drinking
Time Frame
12 Weeks
Title
Percent of days abstinent from heavy drinking
Time Frame
12 Weeks
Title
Percent of days abstinent from any alcohol
Time Frame
12 Weeks
Title
Number of drinks per drinking day
Time Frame
12 Weeks
Title
Days to relapse to first heavy drinking day
Time Frame
12 Weeks
Title
Incidence of Adverse Events
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Alkermes Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alkermes Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Alkermes Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Alkermes Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Alkermes Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Alkermes Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alkermes Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Alkermes Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Alkermes Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30320
Country
United States
Facility Name
Alkermes Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Alkermes Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Alkermes Investigational Site
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Alkermes Investigational Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Alkermes Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Alkermes Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Alkermes Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Alkermes Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Alkermes Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Alkermes Investigational site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Alkermes Investigational Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Alkermes Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Alkermes Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Alkermes Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Alkermes Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Alkermes Investigational Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30055046
Citation
O'Malley SS, Todtenkopf MS, Du Y, Ehrich E, Silverman BL. Effects of the Opioid System Modulator, Samidorphan, on Measures of Alcohol Consumption and Patient-Reported Outcomes in Adults with Alcohol Dependence. Alcohol Clin Exp Res. 2018 Oct;42(10):2011-2021. doi: 10.1111/acer.13849. Epub 2018 Aug 13.
Results Reference
derived
Learn more about this trial
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
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