Effects of Varenicline on Cigarette Self Administration

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00731055
First received: August 6, 2008
Last updated: December 8, 2009
Last verified: December 2009

August 6, 2008
December 8, 2009
February 2008
May 2009   (final data collection date for primary outcome measure)
Cigarette Choice. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00731055 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Varenicline on Cigarette Self Administration
Effects of Varenicline on Cigarette Self Administration

We hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.

Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain and behavior present an opportunity to advance medication development.

The addictive properties of nicotine are thought to be a result of nicotine triggering the acute release of dopamine, a pleasurable event that a person seeks to repeat. Varenicline is a partial agonist of the nicotine receptors, therefore also triggering the release of dopamine but in a more sustained and moderate manner, which could counter the low dopamine levels arising from a lack of nicotine and therefore aid craving. Also, by binding to these nicotine receptors in advance of smoking, it could stop nicotine from binding and creating pleasurable effects.

This study will assess the effect of acute treatment with varenicline and placebo on early tobacco withdrawal, acute effects of cigarettes and cigarette self-administration in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab and receive acute treatment with varying doses of varenicline or placebo and perform computer tests and fill out questionnaires. Then they will be given the opportunity to smoke under operational conditions (cigarette versus money choice). This study will employ a within-group, double-blind, randomized and counterbalanced design.

The main goal of this project is to improve the current laboratory model of smoking cessation and study the mechanism involved in smoking maintenance. We hypothesize that varenicline will dose-dependently: 1) decrease nicotine withdrawal symptoms, 2) decrease acute effects of cigarettes and 3) decrease self-administration of cigarettes in the laboratory paradigm. Showing the effectiveness of varenicline in the proposed laboratory model will confirm the model's predictive validity to detect clinically effective medication.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nicotine Dependence
Drug: Varenicline
4 doses of Varenicline. 1 capsule of either dose (0mg, .5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.
Other Name: Chantix
  • Placebo Comparator: Placebo
    No drug.
    Intervention: Drug: Varenicline
  • Active Comparator: 2
    .5 mg varenicline
    Intervention: Drug: Varenicline
  • Active Comparator: 3
    1 mg varenicline
    Intervention: Drug: Varenicline
  • Active Comparator: 4
    2 mg varenicline
    Intervention: Drug: Varenicline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A DSM-IV diagnosis of nicotine dependence with physiological dependence, smoking at least 15 cigarettes/day during the last 3 months.
  2. Not interested in treatment
  3. Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
  4. Able to perform study procedures
  5. Males or females between the ages of 21-45 yrs
  6. Female participants agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

1. A DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine 2. Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months) 3. Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders 4. Currently seeking treatment for nicotine dependence 5. Participants on parole or probation 6. History of significant recent violent behavior 7. Blood pressure > 150/90 9. History of allergic reaction to any of the study medications.

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Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00731055
NIDA-17572-4, R01DA017572, DPMCDA
Yes
Adam Bisaga, MD, Principal Investigator, New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Adam Bisaga, MD New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP