Clinical trial NCT01351766: Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Official title: Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: Behavioral Activation
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-05-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
measure: Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date
timeFrame: 12 weeks post quit date
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland, College Park
state: Maryland
Study officials:
affiliation: University of Maryland
name: Laura MacPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: