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Relapse Prevention With Varenicline

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrence; Smoking Cessation; Substance-Related Disorders

Intervention: Varenicline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Maxine L Stitzer, PhD, Principal Investigator, Affiliation: Johns Hopkins University

Summary

This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

Clinical Details

Official title: Relapse Prevention With Varenicline

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Primary outcome: Volunteers to relapse and time to relapse

Secondary outcome: Subjective and reinforcing effects of cigarettes

Detailed description: In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18-75 years old

- Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests

positive for nicotine metabolites at intake

- Contemplating a smoking cessation attempt in the near future

- Willing to engage in a practice quit attempt during which they will be asked to smoke

on one occasion

- Able to give informed consent

Exclusion Criteria:

- Currently meets DSM-IV criteria for depression, bi-polar disorder, or schizophrenia

- History of attempted suicide or expresses any current suicidal ideation

- Pregnant, breast feeding, or planning to become pregnant within the next 3 months

- Reports desire for immediate treatment of tobacco/nicotine dependence

- Severe impairment of renal function indicated by GFR less than 30 ml/min calculated

using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)

Locations and Contacts

Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States
Additional Information

Starting date: October 2008
Last updated: May 31, 2012

Page last updated: August 23, 2015

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