Combining a Smoke Ending Aid With Behavioral Treatment - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gariti, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00006151
First received: August 8, 2000
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Tobacco Use Disorder
Behavioral: Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Combining a Smoke Ending Aid With Behavioral Treatment

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Abstinence Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: May 1999
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accu Drops (AD&C)
The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy.
Behavioral: Behavioral Therapy
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
Placebo Comparator: Placebo
The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy.
Behavioral: Behavioral Therapy
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006151

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
Peter Gariti
Investigators
Principal Investigator: Peter W Gariti, Ph.D. University of Pennsylvania
  More Information

Publications:
Responsible Party: Peter Gariti, Sponsor-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00006151     History of Changes
Other Study ID Numbers: NIDA-11645-1, R01DA011645
Study First Received: August 8, 2000
Results First Received: June 24, 2013
Last Updated: November 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
nicotine fading
Accu Drop
cigarette tapering
smoking cessation
motivational interviewing

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014