Nicotine Dependence Clinical Trial
Official title:
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Verified date | August 2013 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 Parkinson's 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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Meet DSM-IV criteria for nicotine dependence with FTND score > 5. - Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month). - At the time of initial evaluation, are motivated to quit smoking in the next 30 days. - Have made at least one unsuccessful attempt to quit smoking in the past year. - At baseline, have expired breath CO level > 10. - Are between ages 18-70 years old. - Weigh at least 100 lbs (45.5 kg, selegiline dose < 0.22 mg/kg). - No previous use of nicotine replacement products in the one month prior to randomization. - Have the capacity to give informed consent, and are English-speaking. Exclusion Criteria: - Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness. - Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine). - Demonstrate serious medical conditions (i.e. abnormal liver function [as evidenced by AST, ALT or bilirubin values 2x ULN], unstable cardiovascular disease, significant blood abnormalities). - Exhibit or have history of clinical hypertension. - Exhibit active peptic ulcer disease. - Are pregnant, are trying to become pregnant, or are currently breastfeeding. - Are on current medication regimes that include antidepressants, or sympathomimetic agents, or meperidine and other meperidine-opioids which may have interactions with selegiline. - Known hypersensitivity to selegiline or NRT. - Are from the same household as another study participant. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Canadian Tobacco Control Research Initiative |
Canada,
Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Cue dependency of nicotine self-administration and smoking. Pharmacol Biochem Behav. 2001 Dec;70(4):515-30. Review. — View Citation
Fowler JS, Volkow ND, Wang GJ, Pappas N, Logan J, Shea C, Alexoff D, MacGregor RR, Schlyer DJ, Zezulkova I, Wolf AP. Brain monoamine oxidase A inhibition in cigarette smokers. Proc Natl Acad Sci U S A. 1996 Nov 26;93(24):14065-9. — View Citation
Henningfield JE, Goldberg SR. Nicotine as a reinforcer in human subjects and laboratory animals. Pharmacol Biochem Behav. 1983 Dec;19(6):989-92. — View Citation
Robinson TE, Berridge KC. Incentive-sensitization and addiction. Addiction. 2001 Jan;96(1):103-14. Review. — View Citation
Robinson TE, Berridge KC. The neural basis of drug craving: an incentive-sensitization theory of addiction. Brain Res Brain Res Rev. 1993 Sep-Dec;18(3):247-91. Review. — View Citation
Stolerman IP, Shoaib M. The neurobiology of tobacco addiction. Trends Pharmacol Sci. 1991 Dec;12(12):467-73. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) | 9 weeks | No | |
Secondary | Last four weeks of Trial Continuous smoking abstinence rates (verified by CO < 10 ppm) | 4 weeks | No | |
Secondary | Seven-day point prevalence smoking abstinence | end of treatment, six-month follow-up | No | |
Secondary | Treatment retention (based on survival analysis and number of weeks a subject completes in the trial) | upon completion | No | |
Secondary | Time line follow back for cigarettes smoked, alcohol and caffeinated beverage use | Weeks 1-8; six-month follow-up | No | |
Secondary | Tobacco craving as assessed by Tiffany scale for smoking urges | Weeks 1, 4 and 8; 6-month follow-up | No | |
Secondary | DSM-IV nicotine withdrawal symptom checklist | Weeks 1, 4 and 8; 6-month follow-up | No |
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