Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271024
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2005-12-28
Brief Title:
Efficacy of Naltrexone in Womens Smoking Cessation
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Efficacy of Naltrexone in Womens Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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
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 womens 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 N324 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 womens 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 naltrexones 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 womens 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 womens smoking cessation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA016834 | NIH | None | httpsreporternihgovquickSearchR01DA016834 |