Smoking Cessation Clinical Trial
Official title:
Efficacy of Naltrexone in Women's Smoking Cessation
Verified date | February 2023 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 333 |
Est. completion date | March 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Chicago, Department of Psychiatry | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Epstein AM, King AC. Naltrexone attenuates acute cigarette smoking behavior. Pharmacol Biochem Behav. 2004 Jan;77(1):29-37. doi: 10.1016/j.pbb.2003.09.017. — View Citation
King A, de Wit H, Riley RC, Cao D, Niaura R, Hatsukami D. Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences. Nicotine Tob Res. 2006 Oct;8(5):671-82. doi: 10.1080/14622200600789767. — View Citation
King AC, Meyer PJ. Naltrexone alteration of acute smoking response in nicotine-dependent subjects. Pharmacol Biochem Behav. 2000 Jul;66(3):563-72. doi: 10.1016/s0091-3057(00)00258-6. — View Citation
King AC. Role of naltrexone in initial smoking cessation: preliminary findings. Alcohol Clin Exp Res. 2002 Dec;26(12):1942-4. doi: 10.1097/01.ALC.0000041003.44118.9B. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date | 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. | 4 Weeks Following Smoking Quit Date (Study week 7) | |
Primary | Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date | 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. | 12 Weeks Following Smoking Quit Date (Study week 15) | |
Primary | 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date | 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 Weeks Following Smoking Quit Date (Study week 7) | |
Primary | 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date | 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. | 12 Weeks Following Smoking Quit Date (Study week 15) | |
Primary | 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date | 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. | 26 Weeks Following Smoking Quit Date (Study week 29) | |
Primary | 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date | 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. | 52 Weeks Following Smoking Quit Date (Study week 55) | |
Secondary | Weight Change at End of Treatment (Smoking Abstinent Only) | 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. | Weight change at 12 weeks post smoking quit date (study week 15) | |
Secondary | Weight Change at End of Treatment (Regardless of Quit Status) | 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. | Weight change at 12 weeks post quit date (study week 15) from smoking quit date | |
Secondary | Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date | 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. | 1-Week Post Quit Date (Study Week 4) | |
Secondary | Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date | 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. | 4-Weeks Post Quit Date (Study Week 7) |
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