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Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000437
First Posted: November 3, 1999
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
  Purpose
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
Alcoholism Smoking 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: Quadruple (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 Barbara J. Mason, 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000437


Locations
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)
Investigators
Principal Investigator: Barbara Mason, PhD University of Miam
  More Information

Responsible Party: Barbara J. Mason, Principal Investigator, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00000437     History of Changes
Other Study ID Numbers: NIAAAMAS11210
R01AA011210 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Naltrexone
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