We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combining a Smoke Ending Aid With Behavioral Treatment - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006151
First Posted: August 9, 2000
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Peter Gariti, University of Pennsylvania
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Peter Gariti, University of Pennsylvania:

Primary Outcome Measures:
  • Abstinence Rate [ Time Frame: 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006151


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
Peter Gariti
National Institute on Drug Abuse (NIDA)
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 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Results First Submitted: June 24, 2013
Results First Posted: January 6, 2014
Last Update Posted: December 3, 2015
Last Verified: December 2015

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

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