Combining a Smoke Ending Aid With Behavioral Treatment - 1

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: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Behavioral Therapy

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

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104 6178
      • University of Pennsylvania

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• 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

General Publications

• 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.

Study record dates

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: smoking cessation; motivational interviewing; nicotine fading; Accu Drop; cigarette tapering
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NIDA-11645-1; R01DA011645 (U.S. NIH Grant/Contract)