Phase 2
Completed N=333
Efficacy of Naltrexone in Women's Smoking Cessation
Source: ClinicalTrials.gov NCT00271024 ↗Enrolled (actual)
333
Serious AEs
1.3%
Results posted
Apr 2013
Primary outcomePrimary: Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date — 43; 29; 40; 39 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date |
43; 29; 40; 39 | — |
| PRIMARY Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date |
23; 12; 17; 23 | — |
| PRIMARY 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date |
47; 33; 49; 43 | — |
| PRIMARY 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date |
31; 24; 30; 31 | — |
| PRIMARY 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date |
22; 18; 20; 22 | — |
| PRIMARY 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date |
14; 15; 14; 20 | — |
| SECONDARY Weight Change at End of Treatment (Smoking Abstinent Only) |
4.79; 5.58; 2.26; 5.08 | — |
| SECONDARY Weight Change at End of Treatment (Regardless of Quit Status) |
5.29; 3.42 | — |
| SECONDARY Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date |
16; 5; 24; 13; 4; 3 | — |
| SECONDARY Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date |
3; 3; 12; 7; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00271024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.