NCT00981617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

10 months

First QC Date

September 21, 2009

Last Update Submit

August 19, 2011

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Percent of subjects abstinent from heavy drinking

    12 Weeks

Secondary Outcomes (6)

  • Percent of subjects abstinent from any drinking

    12 Weeks

  • Percent of days abstinent from heavy drinking

    12 Weeks

  • Percent of days abstinent from any alcohol

    12 Weeks

  • Number of drinks per drinking day

    12 Weeks

  • Days to relapse to first heavy drinking day

    12 Weeks

  • +1 more secondary outcomes

Study Arms (4)

ALKS33 (RDC-0313) (1 mg)

EXPERIMENTAL

1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration

Drug: ALKS33 (RDC-0313) (1 mg)

ALKS33 (RDC-0313) (2.5 mg)

EXPERIMENTAL

2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration

Drug: ALKS33 (RDC-0313) (2.5 mg)

ALKS33 (RDC-0313) (10 mg)

EXPERIMENTAL

10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration

Drug: ALKS33 (RDC-0313) (10 mg)

Placebo

PLACEBO COMPARATOR

Matching placebo (capsules without active study drug) provided for daily oral administration

Drug: Placebo

Interventions

ALKS33 (RDC-0313) (1 mg)DRUG

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

ALKS33 (RDC-0313) (1 mg)
ALKS33 (RDC-0313) (2.5 mg)DRUG

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

ALKS33 (RDC-0313) (2.5 mg)
ALKS33 (RDC-0313) (10 mg)DRUG

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

ALKS33 (RDC-0313) (10 mg)
PlaceboDRUG

Matching placebo taken once daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Alkermes Investigational Site

Tucson, Arizona, 85712, United States

Location

Alkermes Investigational Site

Cerritos, California, 90703, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

San Diego, California, 92102, United States

Location

Alkermes Investigational Site

Jacksonville, Florida, 32216, United States

Location

Alkermes Investigational Site

Maitland, Florida, 32751, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32806, United States

Location

Alkermes Investigational Site

South Miami, Florida, 33143, United States

Location

Alkermes Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30320, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30328, United States

Location

Alkermes Investigational Site

Roswell, Georgia, 30076, United States

Location

Alkermes Investigational Site

Lafayette, Indiana, 47905, United States

Location

Alkermes Investigational Site

Fall River, Massachusetts, 02720, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89146, United States

Location

Alkermes Investigational Site

Albuquerque, New Mexico, 87102, United States

Location

Alkermes Investigational Site

Brooklyn, New York, 11235, United States

Location

Alkermes Investigational Site

New York, New York, 10010, United States

Location

Alkermes Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Alkermes Investigational site

Hickory, North Carolina, 28601, United States

Location

Alkermes Investigational Site

New Bern, North Carolina, 28562, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19118, United States

Location

Alkermes Investigational Site

Houston, Texas, 77090, United States

Location

Alkermes Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Alkermes Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Related Publications (1)

  • 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.

    PMID: 30055046DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

ALKS-33

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

US(27)