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Combining a Smoke Ending Aid With Behavioral Treatment - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Therapy
Sponsored by
Peter Gariti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Accu Drops (AD&C)

Placebo

Arm Description

The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy.

The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy.

Outcomes

Primary Outcome Measures

Abstinence Rate
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2000
Last Updated
December 1, 2015
Sponsor
Peter Gariti
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00006151
Brief Title
Combining a Smoke Ending Aid With Behavioral Treatment - 1
Official Title
Combining a Smoke Ending Aid With Behavioral Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Gariti
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accu Drops (AD&C)
Arm Type
Experimental
Arm Description
The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Therapy
Intervention Description
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
Primary Outcome Measure Information:
Title
Abstinence Rate
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W Gariti, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15223089
Citation
Gariti P, Alterman AI, Lynch KG, Kampman K, Whittingham T. Adding a nicotine blocking agent to cigarette tapering. J Subst Abuse Treat. 2004 Jul;27(1):17-25. doi: 10.1016/j.jsat.2004.03.005.
Results Reference
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Combining a Smoke Ending Aid With Behavioral Treatment - 1

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