Usefulness of Selegiline as an Aid to Quit Smoking - 1

Usefulness of Selegiline for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Drug: Placebo; Drug: Selegiline

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).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • PRISM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo
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 Names: L-deprenyl; Eldepryl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
7 Day Point Prevalence of Cigarette Abstinence	6-month follow up
7 Day Point Prevalence of Cigarette Abstinence	Week 8

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tony P George, M.D., Yale University; Principal Investigator: Marc N Potenza, M.D., Ph.D., Yale University

Publications and helpful links

General Publications

• Weinberger AH, Reutenauer EL, Jatlow PI, O'Malley SS, Potenza MN, George TP. A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. Drug Alcohol Depend. 2010 Mar 1;107(2-3):188-95. doi: 10.1016/j.drugalcdep.2009.10.009. Epub 2009 Nov 24.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 9, 2005
• First Submitted That Met QC Criteria: August 9, 2005
• First Posted (Estimate): August 11, 2005

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Tobacco
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Psychotropic Drugs; Antidepressive Agents; Monoamine Oxidase Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Selegiline
• Other Study ID Numbers: NIDA-15757-1; DPMC (Other Identifier: NIDA); R01DA015757 (U.S. NIH Grant/Contract); R01-15757-1