Alcoholism
Conditions
Brief summary
This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
Interventions
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
UConn Health
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Meets criteria for alcohol dependence. * Abstinent from alcohol for a period of at least 3 days prior to beginning of study. * Able to read English and complete study evaluations. * Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.
Exclusion criteria
* Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis. * Prior history of opioid dependence. * Regular use of psychoactive drugs including anxiolytics and antidepressants. * Prior treatment with naltrexone. * Current use of disulfiram. * Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania). * Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease. * Abstinent longer than 28 days prior to randomization.
Countries
United States
Outcome results
None listed