Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

NCT ID: NCT01351766

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-05-31

Brief Summary

The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.

Detailed Description

1. 18-21 years of age,

2. a regular smoker for at least 6 months

3. currently smoking an average of at least 5 cigarettes per day

4. want to quit smoking

5. report current elevated depressive symptoms

Conditions

Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Activation for Smoking

Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended.

Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.

Group Type: EXPERIMENTAL

Transdermal Nicotine Patch

Intervention Type: DRUG

Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.

Interventions

Transdermal Nicotine Patch

Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.

Intervention Type: DRUG

Other Intervention Names

Nicoderm CQ

Eligibility Criteria

Inclusion Criteria

• between 18 and 21 years of age
• a regular smoker for at least 6 months
• currently smoking an average of at least 5 cigarettes per day
• want to quit smoking
• report current elevated depressive symptoms

Exclusion Criteria

• current Axis I disorder
• psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
• current use of psychotropic medication or participation in any form of psychotherapy
• a history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
• limited mental competency [Mini Mental State Examination score < 23] and/or the inability to give informed, voluntary, written consent to participate
• current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt

• cerebrovascular disease
• high blood pressure
• diabetes
• use of psychotropic medications in 3 weeks prior to participation in fMRI protocol
• exposure to extreme trauma
• lifetime history of mania, psychosis, or pervasive developmental disorder,
• being ambidextrous or left handed
• any metal implants, heart pacemaker, permanent retainer
• tattoos containing metal dyes
• claustrophobia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: lead

Responsible Party

Laura MacPherson

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura MacPherson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

University of Maryland, College Park

College Park, Maryland, United States

Countries

United States

Other Identifiers

R21DA029445

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA029445

Identifier Type: -

Identifier Source: org_study_id