Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00000437
First received: November 2, 1999
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to determine the effectiveness of naltrexone (Revia) in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

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.


Condition Intervention Phase
Alcoholism
Smoking
Drug: naltrexone (Revia)
Drug: nicotine replacement patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
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:

Estimated Enrollment: 166
Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Barbara Mason, PhD University of Miam
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000437     History of Changes
Other Study ID Numbers: NIAAAMAS11210, R01AA011210
Study First Received: November 2, 1999
Last Updated: July 21, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcoholism
Smoking
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Naltrexone
Nicotine polacrilex
Nicotine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on July 24, 2014