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OpenTrials
Completed

NCT Number: NCT00000437

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

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 and smoking in patients with both nicotine and alcohol dependence.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, 33136, United States

About this study

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 coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone Tablet and Nicotine Patch

Drug

Other names: Revia and Nicotrol

Naltrexone Tablet and Placebo Patch

Drug

Other names: Revia

Placebo Tablet and Nicotine Patch

Drug

Other names: Nicotrol

Placebo Tablet and Placebo Patch

Drug

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Nalmefene in Nicotine and Alcohol Dependence

Important dates

Study start
1997
Primary completion
2005
Study completion
2005
First posted
Nov 3, 1999
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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