Status:

COMPLETED

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Lead Sponsor:

The Scripps Research Institute

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Smoking

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking an...

Detailed Description

Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly cop...

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Currently meets criteria for dependence on substances other than alcohol and nicotine.
  • Any 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.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.
  • Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.
  • Inability to understand and/or comply with the provisions of the protocol and consent form.
  • Treatment with an investigational drug during the previous month.
  • Chronic treatment with any narcotic-containing medications during the previous month.
  • Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.
  • Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
  • More than 6 weeks of abstinence.

Key Trial Info

Start Date :

September 26 1997

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 15 2005

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00000437

Start Date

September 26 1997

End Date

September 15 2005

Last Update

April 20 2017

Active Locations (1)

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Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, United States, 33136