Combining a Smoke Ending Aid With Behavioral Treatment - 1

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

Detailed Description
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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.

Official Title
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Combining a Smoke Ending Aid With Behavioral Treatment

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accu Drops (AD&C)<br>The experimental group (N=30) will be prescribed active Accu Drops (AD&C) plus behavioral therapy. | Behavioral: Behavioral Therapy<br>* Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.<br>|
| Placebo Comparator: Placebo<br>The control condition (N=30) will be prescribed placebo Accu Drops (PD&C) plus behavioral therapy. | Behavioral: Behavioral Therapy<br>* Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine fading, Accu Drop, cigarette tapering, smoking cessation, motivational interviewing