Naltrexone Maintenance Treatment of Alcoholism

T

The Scripps Research Institute

Status and phase

Completed
Phase 4

Conditions

Alcoholism

Treatments

Drug: Matched Placebo Tablet
Drug: Naltrexone Tablet

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000450
R01AA010518 (U.S. NIH Grant/Contract)
NIAAAMAS10518

Details and patient eligibility

About

The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.

Enrollment

159 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Meets criteria for alcohol dependence.
  • Expresses a desire to cut down or stop drinking.

Exclusion criteria

  • Currently meets criteria for dependence on substances other than alcohol.
  • History of opiate dependence or evidence of current opiate use.
  • Significant medical disorders that will increase potential risk or interfere with study participation.
  • Liver function tests more than 3 times normal or elevated bilirubin.
  • Female patients who are pregnant, nursing, or not using a reliable method of birth control.
  • Inability to understand and provide a consent form.
  • Treatment with an investigational drug during the previous month.
  • Prior treatment with naltrexone.
  • Chronic treatment with any narcotic-containing medications during the previous month.
  • Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
  • Current treatment with disulfiram.
  • More than 6 weeks of abstinence.
  • Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

159 participants in 2 patient groups, including a placebo group

Naltrexone Tablet
Active Comparator group
Treatment:
Drug: Naltrexone Tablet
Matched Placebo Tablet
Placebo Comparator group
Treatment:
Drug: Matched Placebo Tablet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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