Naltrexone for Relapse Prevention

U

UConn Health

Status and phase

Completed
Phase 4

Conditions

Alcoholism

Treatments

Drug: naltrexone (Revia)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000442
NIAAAKRA3510
P50AA003510 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems