Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence (EDC)

Harvard University Faculty of Medicine

Status and phase: Unknown; Phase 4

Conditions: Tobacco Addiction

Treatments: Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01038414

5R01DA12165-8

5R01DA012165 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups, including a placebo group

Brief-Duration Counseling

Placebo Comparator group

Description:

3-Month Duration

Treatment:

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Moderate Duration Counseling

Active Comparator group

Description:

6-Month Duration

Treatment:

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Extended Duration Counseling

Active Comparator group

Description:

12-Month Duration

Treatment:

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling