Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390923
Status:
TERMINATED
Last Update Posted:
2013-08-29
First Post:
2006-10-19
Brief Title:
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary results did not support the utility of combining selegeline NRT
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test a new medication strategy designed to help smokers quit It will combine selegiline a drug currently approved and available for the treatment of Parkinsons disease with a nicotine skin patch Forty nicotine-dependent smokers will enrolled in this study Twenty will receive placebo inactive pill plus nicotine patch and twenty will receive selegiline plus nicotine patch Once enrolled in the study subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior a brief health check collection of breath and urine samples necessary to drug levels and nicotine levels and receive brief individual counseling designed to help them stop smoking The medication phase of this study lasts 9 weeks A follow-up visit will be conducted six months after trial completion At that point health and behavioral measures will be re-assessed
Detailed Description:
This pilot study utilizes a double-blind two-armed design to evaluate the efficacy of combining oral selegiline with transdermal nicotine patch for smoking cessation in 40 nicotine-dependent smokers After successful completion of 3 screening visits to ensure medical and psychiatric eligibility criteria are met subjects will be randomized into one of two experimental groups
1 selegiline 10 mgday NRT 21 mg24 hr
2 matching placebo NRT 21 mg24 hr
Randomization will be performed through the use a random number list to generate 50 selegiline50 placebo and also 50 male50 female within each of those treatment groups
Participants will begin selegiline or placebo once a day during Week 1 and dose will be graduated to full study dosage 10 mgday by adding an evening intake am and pm dosing for Weeks 2-8 Day 15 of the trial represents target quit day and the transdermal nicotine patch 21 mg24hr will be applied at this time Patches will be worn in conjunction with study medication for Weeks 3-8 after which the patch will be removed and study medication tapered throughout Week 9
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide breath urine and blood samples as required receive brief smoking cessation counseling and complete questionnaires regarding their smoking behavior and psychological state A post-trial physical will be conducted upon completion of Week 9 Monthly follow-up phone interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a 6-month follow-up
Trial Objectives
1 To determine if combination of selegiline hydrochloride and NRT full substitution to tobacco is superior to NRT alone placebo partial substitution for smoking cessation in nicotine dependent smokers
The primary hypothesis is that full substitution selegiline NRT will be superior to placebo NRT for achievement of 7-day point prevalence smoking abstinence rates at the end of trial abstinence rates Day 49-56 assessment in nicotine-dependent cigarette smokers
Secondary hypothesis 1a is that full substitution selegiline NRT will be superior to NRT for achievement of last four weeks of trial Days 29-56 smoking abstinence rates in nicotine-dependent cigarette smokers
Secondary hypothesis 1b is that full substitution selegiline NRT will be superior to NRT for achievement 6-month post target quit date smoking abstinence rates in nicotine-dependent cigarette smokers
2 To determine if treatment retention and study medication compliance will be higher in the full substitution selegiline NRT group as compared to the NRT group during the 8-week smoking cessation trial
Hypothesis 2 is that treatment retention and study medication compliance will be higher in the full substitution selegiline NRT group as compared to the NRT group during the 8-week smoking cessation trial
3 To determine if full substitution selegiline NRT reduces nicotine craving and withdrawal symptoms as compared to NRT group during the 8-week smoking cessation trial
Hypothesis 3 is that full substitution treatment will lead to significant reductions in tobacco withdrawal and craving ratings compared to NRT group
4 To determine adverse events profile in nicotine-dependent smokers of the combination of selegiline and NRT as compared to NRT
Hypothesis 4 is that selegiline in combination with NRT will be well-tolerated and that rates of adverse events will not be significantly different between subjects assigned to full substitution as compared to NRT group
1 selegiline 10 mgday NRT 21 mg24 hr
2 matching placebo NRT 21 mg24 hr
Randomization will be performed through the use a random number list to generate 50 selegiline50 placebo and also 50 male50 female within each of those treatment groups
Participants will begin selegiline or placebo once a day during Week 1 and dose will be graduated to full study dosage 10 mgday by adding an evening intake am and pm dosing for Weeks 2-8 Day 15 of the trial represents target quit day and the transdermal nicotine patch 21 mg24hr will be applied at this time Patches will be worn in conjunction with study medication for Weeks 3-8 after which the patch will be removed and study medication tapered throughout Week 9
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide breath urine and blood samples as required receive brief smoking cessation counseling and complete questionnaires regarding their smoking behavior and psychological state A post-trial physical will be conducted upon completion of Week 9 Monthly follow-up phone interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a 6-month follow-up
Trial Objectives
1 To determine if combination of selegiline hydrochloride and NRT full substitution to tobacco is superior to NRT alone placebo partial substitution for smoking cessation in nicotine dependent smokers
The primary hypothesis is that full substitution selegiline NRT will be superior to placebo NRT for achievement of 7-day point prevalence smoking abstinence rates at the end of trial abstinence rates Day 49-56 assessment in nicotine-dependent cigarette smokers
Secondary hypothesis 1a is that full substitution selegiline NRT will be superior to NRT for achievement of last four weeks of trial Days 29-56 smoking abstinence rates in nicotine-dependent cigarette smokers
Secondary hypothesis 1b is that full substitution selegiline NRT will be superior to NRT for achievement 6-month post target quit date smoking abstinence rates in nicotine-dependent cigarette smokers
2 To determine if treatment retention and study medication compliance will be higher in the full substitution selegiline NRT group as compared to the NRT group during the 8-week smoking cessation trial
Hypothesis 2 is that treatment retention and study medication compliance will be higher in the full substitution selegiline NRT group as compared to the NRT group during the 8-week smoking cessation trial
3 To determine if full substitution selegiline NRT reduces nicotine craving and withdrawal symptoms as compared to NRT group during the 8-week smoking cessation trial
Hypothesis 3 is that full substitution treatment will lead to significant reductions in tobacco withdrawal and craving ratings compared to NRT group
4 To determine adverse events profile in nicotine-dependent smokers of the combination of selegiline and NRT as compared to NRT
Hypothesis 4 is that selegiline in combination with NRT will be well-tolerated and that rates of adverse events will not be significantly different between subjects assigned to full substitution as compared to NRT group
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