Combining a Smoke Ending Aid With Behavioral Treatment - 1

Peter Gariti

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Behavioral: Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006151

R01DA011645 (U.S. NIH Grant/Contract)

NIDA-11645-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Accu Drops (AD&C)

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Therapy

Placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Behavioral Therapy