Combining a Smoke Ending Aid With Behavioral Treatment - 1

Tobacco Use Disorder Clinical Trial

Official title:

Combining a Smoke Ending Aid With Behavioral Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006151
• Other study ID #: NIDA-11645-1
• Secondary ID: R01DA011645
• Status: Completed
• Phase: N/A
• First received: August 8, 2000
• Last updated: December 1, 2015
• Start date: May 1999
• Est. completion date: February 2002

Study information

• Verified date: December 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Behavioral Therapy
Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Peter Gariti	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No