Combining a Smoke Ending Aid With Behavioral Treatment - 1
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Purpose
The purpose of this study is to combine a smoke ending aid with behavioral treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Use Disorder |
Behavioral: Behavioral Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Combining a Smoke Ending Aid With Behavioral Treatment |
- To determine the combination or combinations of pharmacotherapy (either bupropion or the nicotine patch) and either high or low intensity adjunctive counseling (Mayo vs. medical management) that are most effective as well as cost-effective. [ Time Frame: 1 year ]
| Enrollment: | 260 |
| Study Start Date: | May 1999 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: Behavioral Therapy
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| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 6178 | |
| Principal Investigator: | Peter W Gariti, Ph.D. | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Peter Gariti, Ph.D., University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00006151 History of Changes |
| Other Study ID Numbers: | NIDA-11645-1, R01-11645-1 |
| Study First Received: | August 8, 2000 |
| Last Updated: | June 16, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013