MedDataX Logo

Combining a Smoke Ending Aid With Behavioral Treatment - 1

NCT ID: NCT00006151

Last Updated: 2015-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2002-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accu Drops (AD&C)

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

Group Type EXPERIMENTAL

Behavioral Therapy

Intervention Type BEHAVIORAL

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Behavioral Therapy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Peter Gariti

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Gariti

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter W Gariti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15223089 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA011645

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-11645-1

Identifier Type: -

Identifier Source: org_study_id