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Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute Identifier:
First received: November 2, 1999
Last updated: April 18, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Drug: Naltrexone Tablet and Nicotine Patch
Drug: Naltrexone Tablet and Placebo Patch
Drug: Placebo Tablet and Nicotine Patch
Drug: Placebo Tablet and Placebo Patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:
Double blind tablet and patch active study medications, and matched tablet and patch placebos
Primary Purpose: Treatment
Official Title: Nalmefene in Nicotine and Alcohol Dependence

Resource links provided by NLM:

Further study details as provided by The Scripps Research Institute:

Enrollment: 60
Actual Study Start Date: September 26, 1997
Study Completion Date: September 15, 2005
Primary Completion Date: September 15, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone Tablet and Nicotine Patch Drug: Naltrexone Tablet and Nicotine Patch
Other Name: Revia and Nicotrol
Active Comparator: Naltrexone Tablet and Placebo Patch Drug: Naltrexone Tablet and Placebo Patch
Other Name: Revia
Active Comparator: Placebo Tablet and Nicotine Patch Drug: Placebo Tablet and Nicotine Patch
Other Name: Nicotrol
Placebo Comparator: Placebo Tablet and Placebo Patch Drug: Placebo Tablet and Placebo Patch

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 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00000437

United States, Florida
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Barbara Mason, PhD University of Miam
  More Information

Responsible Party: Barbara J. Mason, Principal Investigator, The Scripps Research Institute Identifier: NCT00000437     History of Changes
Other Study ID Numbers: NIAAAMAS11210
R01AA011210 ( US NIH Grant/Contract Award Number )
Study First Received: November 2, 1999
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Sensory System Agents processed this record on April 27, 2017