Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Smoking Clinical Trial

Official title:

Nalmefene in Nicotine and Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000437
• Other study ID #: NIAAAMAS11210
• Secondary ID: R01AA011210
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: April 18, 2017
• Start date: September 26, 1997
• Est. completion date: September 15, 2005

Study information

• Verified date: April 2017
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and smoking in patients with both nicotine and alcohol dependence.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2005
• Est. primary completion date: September 15, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• Smoking

Intervention

Drug:
• Naltrexone Tablet and Nicotine Patch

• Naltrexone Tablet and Placebo Patch

• Placebo Tablet and Nicotine Patch

• Placebo Tablet and Placebo Patch

Locations

Country	Name	City	State
United States	Department of Psychiatry, University of Miami School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,