Clinical Trials Directory

Trials / Completed

CompletedNCT01351766

Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
39 (actual)
Sponsor
University of Maryland, College Park · Academic / Other
Sex
All
Age
18 Years – 21 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGTransdermal Nicotine PatchTransdermal 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.

Timeline

Start date
2010-04-01
Primary completion
2013-05-01
Completion
2013-05-01
First posted
2011-05-11
Last updated
2022-05-18
Results posted
2020-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01351766. Inclusion in this directory is not an endorsement.