Search / Trial NCT00000437

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Launched by THE SCRIPPS RESEARCH INSTITUTE · Nov 2, 1999

Trial Information

Current as of December 27, 2024

Completed

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

Trial Officials

Barbara Mason, PhD

Principal Investigator

University of Miam

About The Scripps Research Institute

The Scripps Research Institute is a renowned non-profit biomedical research organization dedicated to advancing scientific knowledge and innovation in the life sciences. With a mission to enhance human health through groundbreaking research, Scripps Research conducts pioneering studies across various fields, including drug discovery, molecular biology, and immunology. The institute fosters a collaborative environment that integrates interdisciplinary approaches and state-of-the-art technologies, aiming to translate scientific discoveries into novel therapeutic interventions. Committed to excellence in research and education, Scripps Research plays a pivotal role in shaping the future of medicine and improving patient outcomes globally.

Locations

Miami, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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