Usefulness of Selegiline as an Aid to Quit Smoking - 1

NCT00129311 | Completed Phase 2 Results DMC

• 4 other identifiers: NIDA-15757-1R01DA015757R01-15757-1DPMC
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Cessation

Keywords

Tobacco

Outcome Measures

Primary Outcomes (2)

• 7 Day Point Prevalence of Cigarette Abstinence

  6-month follow up

• 7 Day Point Prevalence of Cigarette Abstinence

  Week 8

Study Arms (2)

1

EXPERIMENTAL

Selegiline

Drug: Selegiline

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Selegiline DRUG

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.

Also known as: L-deprenyl; Eldepryl®

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

PRISM

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

• 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.

  PMID: 19939587 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Andrea Weinberger
• Organization: Yale Unviersity

andrea.weinberger@yale.edu

203-974-7598

Study Officials

• Tony P George, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Marc N Potenza, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 11, 2005
• Study Start: July 1, 2004
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 31, 2015
• Results First Posted: July 16, 2014

Record last verified: 2014-07

Locations

US (1)