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

H

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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