Combining a Smoke Ending Aid With Behavioral Treatment - 1

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Behavioral Therapy

• Registration Number: NCT00006151
• Lead Sponsor: Peter Gariti

Brief Summary

The purpose of this study is to combine a smoke ending aid with behavioral treatment.

Detailed Description

The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (\*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2000-08-08
• Study First Submitted QC: 2000-08-08
• Study First Posted: 2000-08-09
• Primary Completion: 2002-02
• Study Completion: 2002-02
• Results First Submitted: 2013-06-24
• Results First Submitted QC: 2013-11-15
• Results First Posted: 2014-01-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 21 years of age or older, and no greater than 65 years of age
• Medically stable
• Smoke at least 15 filtered cigarettes daily
• Motivated to quit smoking

Exclusion Criteria

• Medically unstable
• Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accu Drops (AD&C)	Behavioral Therapy	The experimental group (N=30) will be prescribed active Accu Drops (AD\&C) plus behavioral therapy.
Placebo	Behavioral Therapy	The control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) plus behavioral therapy.

Primary Outcome Measures

Name	Time	Method
Abstinence Rate	1 year	The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States