Usefulness of Selegiline as an Aid to Quit Smoking - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00129311
First received: August 9, 2005
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.


Condition Intervention Phase
Tobacco Use Cessation
Drug: Selegiline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Usefulness of Selegiline for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
  • 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: July 2004
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Selegiline
Drug: Selegiline
5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
Other Name: L-deprenyl; Eldepryl®
Placebo Comparator: 2
Placebo
Drug: Placebo

Detailed Description:

Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence, there is still a significant proportion of cigarette smokers who are unable to quit smoking. Therefore, new and effective pharmacotherapies for smoking cessation are needed. The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation.

In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week, double-blind, placebo-controlled trial and then will be followed over 4 years. Participants will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg will be taken once a day during the first week. This will be increased to 5 mg twice daily for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days 49-56).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for nicotine dependence with a Fagerstrom Test of Nicotine Dependence (FTND) score greater than 5
  • Smokes at least 15 cigarettes daily (averaged over 1 week, within the month prior to enrollment)
  • Motivated to quit smoking within 30 days at time of initial evaluation
  • At least one unsuccessful attempt to quit smoking in the past year
  • An expired breath CO level greater than 10 ppm and baseline plasma cotinine level greater than 150 ng/ml at initial evaluation
  • Body weight of at least 100 lb
  • Avoidance of nicotine replacement product use one month prior to enrollment
  • Speaks English

Exclusion Criteria:

  • Currently taking over-the-counter or prescription sympathomimetic agents (e.g., pseudoephedrine, methylphenidate), antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
  • Serious medical disorders such as unstable angina or liver failure
  • Abnormalities in baseline bloodwork (e.g., threefold elevation of liver function tests, electrolyte abnormalities)
  • Physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) during the 6 months prior to enrollment (based on a clinical evaluation, which includes a self-report, and is confirmed by a positive urine toxicology screen)
  • Meets DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder, or post-traumatic stress disorder
  • Current or past history of bipolar disorder or schizophrenia
  • Past history of major depression associated with historical evidence of suicidal or homicidal behavior, or psychotic symptoms
  • Currently residing with another study participant
  • Presence of suicidal or homicidal ideation
  • Significant impairment of social or occupational functioning, either at time of initial evaluation or during the trial
  • Known hypersensitivity to selegiline hydrochloride
  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: NCT00129311

Locations
United States, Connecticut
PRISM
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Tony P George, M.D. Yale University
Principal Investigator: Marc N Potenza, M.D., Ph.D. Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00129311     History of Changes
Other Study ID Numbers: NIDA-15757-1, R01DA015757, R01-15757-1, DPMC
Study First Received: August 9, 2005
Results First Received: June 16, 2014
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 23, 2014