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Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence

This study has been terminated.
(Preliminary results did not support the utility of combining selegeline + NRT.)
Sponsor:
Collaborator:
Canadian Tobacco Control Research Initiative
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00390923
First received: October 19, 2006
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Nicotine Dependence
Drug: Selegiline + nicotine replacement therapy
Drug: placebo + nicotine replacement therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Last four weeks of Trial Continuous smoking abstinence rates (verified by CO < 10 ppm) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Seven-day point prevalence smoking abstinence [ Time Frame: end of treatment, six-month follow-up ] [ Designated as safety issue: No ]
  • Treatment retention (based on survival analysis and number of weeks a subject completes in the trial) [ Time Frame: upon completion ] [ Designated as safety issue: No ]
  • Time line follow back for cigarettes smoked, alcohol and caffeinated beverage use [ Time Frame: Weeks 1-8; six-month follow-up ] [ Designated as safety issue: No ]
  • Tobacco craving as assessed by Tiffany scale for smoking urges [ Time Frame: Weeks 1, 4 and 8; 6-month follow-up ] [ Designated as safety issue: No ]
  • DSM-IV nicotine withdrawal symptom checklist [ Time Frame: Weeks 1, 4 and 8; 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Selegiline + nicotine replacement therapy
Participants will begin selegiline once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) 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.
Placebo Comparator: 2 Drug: placebo + nicotine replacement therapy
Participants will begin placebo once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390923

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Tobacco Control Research Initiative
Investigators
Principal Investigator: Bernard Le Foll, MD, PhD Centre for Addiction and Mental Health
  More Information

Publications:
Responsible Party: Bernard Le Foll, MD, PhD, CCFP, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00390923     History of Changes
Other Study ID Numbers: 170/2006
Study First Received: October 19, 2006
Last Updated: August 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
smoking
nicotine dependence
double-blind
placebo-controlled
randomized
full substitution therapy
selegiline

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014