Clinical trial NCT00981617: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Percent of subjects abstinent from heavy drinking
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percent of subjects abstinent from any drinking
timeFrame: 12 Weeks
measure: Percent of days abstinent from heavy drinking
timeFrame: 12 Weeks
measure: Percent of days abstinent from any alcohol
timeFrame: 12 Weeks
measure: Number of drinks per drinking day
timeFrame: 12 Weeks
measure: Days to relapse to first heavy drinking day
timeFrame: 12 Weeks
measure: Incidence of Adverse Events
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Cerritos
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Maitland
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: South Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Lafayette
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Fall River
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Alkermes Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Alkermes Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Charlotte
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Alkermes Investigational site
state: North Carolina
city: New Bern
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Alkermes Investigational Site
state: Utah
city: Middleton
country: United States
facility: Alkermes Investigational Site
state: Wisconsin
Study officials:
References:
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.