Effects of Varenicline on Cigarette Self Administration

NCT00731055 | Completed Phase 2 Results DMC

• 3 other identifiers: #5649/NIDA-17572-4R01DA017572DPMCDA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators 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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Cigarette Choice

  Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.

  During each of the four weekly 6-hour experimental sessions

Study Arms (4)

Intervention 1

EXPERIMENTAL

Each participant participates in 4 consecutive interventions in random order. 1. Placebo, 1 capsule before the session 2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session 4\. 2 mg varenicline, 1 capsule before the session

Drug: Varenicline; Drug: Placebo

Intervention 2

EXPERIMENTAL

Each participant participates in 4 consecutive interventions in random order. 1.0.5 mg varenicline, 1 capsule before the session 2. 1 mg varenicline, 1 capsule before the session 3.2 mg varenicline, 1 capsule before the session 4. Placebo, 1 capsule before the session

Drug: Varenicline; Drug: Placebo

Intervention 3

EXPERIMENTAL

Each participant participates in 4 consecutive interventions in random order. 1.1 mg varenicline, 1 capsule before the session 2. 2 mg varenicline, 1 capsule before the session 3.Placebo, 1 capsule before the session 4. 0.5 mg varenicline, 1 capsule before the session

Drug: Varenicline; Drug: Placebo

Intervention 4

EXPERIMENTAL

Each participant participates in 4 consecutive interventions in random order. 1.2 mg varenicline, 1 capsule before the session 2. Placebo, 1 capsule before the session 3. 0.5 mg varenicline, 1 capsule before the session 4. 1 mg varenicline, 1 capsule before the session

Drug: Varenicline; Drug: Placebo

Interventions

Varenicline DRUG

4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.

Also known as: Chantix

Intervention 1; Intervention 2; Intervention 3; Intervention 4

Placebo DRUG

1 dose of placebo

Intervention 1; Intervention 2; Intervention 3; Intervention 4

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Adam Bisaga
• Organization: New York State Psychiatric Institute

amb107@columbia.edu

646-774-6155

Study Officials

• Adam Bisaga, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 18, 2018
• Results First Posted: May 1, 2015

Record last verified: 2018-05

Locations

US (1)