Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Smoking Clinical Trial

Official title:

Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351766
• Other study ID #: DA029445
• Secondary ID: R21DA029445
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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

Additional Exclusion criteria only for the fMRI portion:

• 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.

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Maryland, College Park	College Park	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date	7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks	12 weeks post quit date