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
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Varenicline on Cigarette Self Administration

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cigarette Choice. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
No drug.
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
Active Comparator: 2
.5 mg varenicline
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
Active Comparator: 3
1 mg varenicline
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
Active Comparator: 4
2 mg varenicline
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00731055

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Adam Bisaga, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: Adam Bisaga, MD, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00731055     History of Changes
Other Study ID Numbers: NIDA-17572-4, R01DA017572, DPMCDA
Study First Received: August 6, 2008
Last Updated: December 8, 2009
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014