Status:
COMPLETED
Efficacy of Naltrexone in Women's Smoking Cessation
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessa...
Detailed Description
Although women may be particularly susceptible to the damaging effects of chronic cigarette smoking, evidence indicates that they may have more difficulty in maintaining smoking cessation than men. Gi...
Eligibility Criteria
Inclusion
- Age 18-65, male or female
- Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
- Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
- Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
- Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
- Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
- Reports not quitting smoking in the past three months for more than one week duration
- Agrees to attend behavioral counseling sessions and complete study measures
- Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend
Exclusion
- Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
- Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
- Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
- Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
- Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
- History of adverse reaction to opioid antagonist or nicotine replacement treatment
- Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
- Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
- Unwillingness to agree to DNA analysis.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00271024
Start Date
December 1 2005
End Date
March 1 2010
Last Update
March 23 2023
Active Locations (1)
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1
The University of Chicago, Department of Psychiatry
Chicago, Illinois, United States, 60637