Recruiting

Behavioral CounselingDuration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Sponsor:

Harvard University Faculty of Medicine

Code:

NCT01038414

Conditions

Tobacco Addiction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Extended Duration Behavioral Smoking Cessation Counseling

Study Details

Brief summary:

The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.

Conditions

Tobacco Addiction

Study ID

NCT01038414

Start date

Feb, 2008

Status verified date

Jun, 2011

Completion date

Jan, 2013

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Daily Cigarette Smokers

Exclusion Criteria:

Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease.
Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Brief-Duration Counseling

3-Month Duration

active comparator: Moderate Duration Counseling

6-Month Duration

active comparator: Extended Duration Counseling

12-Month Duration

Interventions

Extended Duration Behavioral Smoking Cessation Counseling

Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling

Primary outcome measure

Proportion of subjects abstinent by treatment group at 1 year post-cessation. [ Time Frame: One year ]

Central Contacts and Locations

Locations

Harvard School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Arthur J Garvey, PhD

617-523-8558 arthur_garvey@hms.harvard.edu

Principal Investigator:

Arthur J Garvey, Ph.D.

More Information

Sponsor

Harvard University Faculty of Medicine

Last update posted

Jun 23, 2011

Last verified

Jun, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard University Faculty of Medicine on 2011-06-23.