Combining a Smoke Ending Aid With Behavioral Treatment - 1

December 1, 2015 updated by: Peter Gariti

Combining a Smoke Ending Aid With Behavioral Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104 6178
        • UNIVERSITY of PENNSYLVANIA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Gariti

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Peter W Gariti, Ph.D., UNIVERSITY of PENNSYLVANIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

August 8, 2000

First Submitted That Met QC Criteria

August 8, 2000

First Posted (Estimate)

August 9, 2000

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-11645-1
  • R01DA011645 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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