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Efficacy of Naltrexone in Women's Smoking Cessation

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.
 
ClinicalTrials.gov Identifier: NCT00271024
Recruitment Status : Completed
First Posted : December 29, 2005
Results First Posted : April 26, 2013
Last Update Posted : March 23, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago

Study Description
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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 cessation treatment with nicotine patch and counseling.

Hypotheses:

  1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
  2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
  3. These effects are predicted to be stronger in women compared to men.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Drug: Naltrexone (drug) Drug: Placebo (for Naltrexone) Phase 2

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. Given women's reduced response to nicotine replacement and other traditional treatments to habitual cigarette smoking, more targeted pharmacotherapy and intervention strategies may be necessary to improve their quit rates. Preliminary data by our group and others indicate that the opioid antagonist naltrexone may be an effective adjunctive pharmacotherapy approach for female smokers. The purpose of the proposed study is to conduct a randomized clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Participants (N=324) will be randomized to receive either naltrexone or placebo starting one week prior to the quit date (25 mg for three days; 50 mg thereafter) and continue for 12 weeks after the quit date. The effects of naltrexone will be evaluated during the pre-quit date period, initial smoking cessation, relapse prevention, and at one year follow-up. It is hypothesized that sex will moderate the effects of naltrexone on outcome, with naltrexone improving prolonged abstinence quit rates in women but not in men. The secondary goal will be to elucidate the mechanism underlying women's treatment response to naltrexone. Weight (relative weight gain and weight concerns) and smoking-related variables (reduced cigarette pleasure, taste, craving and relief of negative withdrawal affect) may be important factors by which naltrexone improves quit rates in women. Medication compliance, psychosocial stress and levels of naltrexone's metabolite, 6-B-naltrexol, will also be examined. In sum, the proposed clinical trial will provide a comprehensive study of sex differences in response to adjunct treatment with naltrexone for smoking cessation. Given the public health concerns and significant health consequences of women's continued high rates of smoking, the proposed study may provide important information on a novel treatment strategy targeting the endogenous opioid system to selectively aid in women's smoking cessation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Naltrexone in Women's Smoking Cessation
Study Start Date : December 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Male Naltrexone
50 mg Naltrexone tablet
 Drug: Naltrexone (drug)
50 mg q.d. for 13 weeks
Experimental: Female Naltrexone
Females receiving either naltrexone (50 mg)
 Drug: Naltrexone (drug)
50 mg q.d. for 13 weeks
Placebo Comparator: Male Placebo
Males receiving Placebo (sugar pill)
 Drug: Placebo (for Naltrexone)
Sugar pill manufactured to mimic Naltrexone tablet
Placebo Comparator: Female Placebo
Females receiving placebo (sugar pill)
 Drug: Placebo (for Naltrexone)
Sugar pill manufactured to mimic Naltrexone tablet


Outcome Measures
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Primary Outcome Measures :
  1. Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date [ Time Frame: 4 Weeks Following Smoking Quit Date (Study week 7) ]
    Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.

  2. Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date [ Time Frame: 12 Weeks Following Smoking Quit Date (Study week 15) ]
    Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.

  3. 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date [ Time Frame: 4 Weeks Following Smoking Quit Date (Study week 7) ]
    7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  4. 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date [ Time Frame: 12 Weeks Following Smoking Quit Date (Study week 15) ]
    7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  5. 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date [ Time Frame: 26 Weeks Following Smoking Quit Date (Study week 29) ]
    7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  6. 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date [ Time Frame: 52 Weeks Following Smoking Quit Date (Study week 55) ]
    7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.


Secondary Outcome Measures :
  1. Weight Change at End of Treatment (Smoking Abstinent Only) [ Time Frame: Weight change at 12 weeks post smoking quit date (study week 15) ]
    Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.

  2. Weight Change at End of Treatment (Regardless of Quit Status) [ Time Frame: Weight change at 12 weeks post quit date (study week 15) from smoking quit date ]
    Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.

  3. Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date [ Time Frame: 1-Week Post Quit Date (Study Week 4) ]
    Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.

  4. Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date [ Time Frame: 4-Weeks Post Quit Date (Study Week 7) ]
    Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-65, male or female
  2. Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
  3. Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview
  4. Relatively healthy, with no medical or psychiatric conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
  5. Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
  6. Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
  7. Reports not quitting smoking in the past three months for more than one week duration
  8. Agrees to attend behavioral counseling sessions and complete study measures
  9. Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend

Exclusion Criteria:

  1. Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
  2. 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
  3. Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
  4. Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
  5. 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
  6. History of adverse reaction to opioid antagonist or nicotine replacement treatment
  7. Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
  8. 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
  9. Unwillingness to agree to DNA analysis.
Contacts and Locations
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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): NCT00271024


Locations
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United States, Illinois
The University of Chicago, Department of Psychiatry
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Andrea C King, PhD The University of Chicago, Department of Psychiatry
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00271024    
Other Study ID Numbers: 13976A (R01 DA016834)
R01DA016834 ( U.S. NIH Grant/Contract )
First Posted: December 29, 2005    Key Record Dates
Results First Posted: April 26, 2013
Last Update Posted: March 23, 2023
Last Verified: February 2023
Keywords provided by University of Chicago:
Smoking
Smoking Cessation
Additional relevant MeSH terms:
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Naltrexone
Alcohol Deterrents
Narcotic Antagonists
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents