A Phase 1/2 interventional study of Standard Treatment and BAD-AS in Cigarette Smoking and Drug Use, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Maryland, College Park · Phase 1/2, Interventional, and Treatment
The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.
This project will take place in two phases. In the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS (which includes ST and NRT). Based on the outcome of this preliminary trial, the BA-DAS protocol will be further refined and readied for larger-scale clinical trials to develop a comprehensive approach to treating smoking among low income, largely minority, depressed smokers in residential drug use treatment, which may be instrumental in reducing smoking among this especially at risk group.
132 studies on the registry are indexed under Cigarette Smoking; 60 are open to participants now.
This study's enrollment of 96 is close to the median of 94 across 114 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
Behavioral: Standard Treatment · Drug: Transdermal Nicotine Patch
The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
Behavioral: BAD-AS · Drug: Transdermal Nicotine Patch
Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
Also known as: ST
The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
8 weeks of the Transdermal Nicotine Patch Nicoderm CQ 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 the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch.
Also known as: Nicoderm CQ
Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
7 days of smoking abstinence confirmed biochemically at 26 weeks
Time frame: 26 weeks post quit date
| Milestone | Standard Smoking Cessation | BA for Substance Abusing Smokers |
|---|---|---|
| Started | 47 | 49 |
| Completed | 43 | 46 |
| Not completed | 4 | 3 |
7 days of smoking abstinence confirmed biochemically at 26 weeks
| Participants | Standard Smoking Cessation | BA for Substance Abusing Smokers |
|---|---|---|
| Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date | 5 | 1 |
Collected over 3 years, 3 months. Adverse events were monitored through study completion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Smoking Cessation | 1/47 (2.1%) | 0/47 (0%) | 0/47 (0%) |
| BA for Substance Abusing Smokers | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
Analysis population is not different from the assignment in Participant Flow.
| Age, Categorical(Participants) | Standard Smoking Cessation | BA for Substance Abusing Smokers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 49 | 94 |
| >=65 years | 2 | 0 | 2 |
| Age, Continuous(years) | Standard Smoking Cessation | BA for Substance Abusing Smokers | Total |
|---|---|---|---|
| Mean | 43.98 ± 9.69 | 42.57 ± 10.58 | 43.25 ± 10.13 |
| Sex: Female, Male(Participants) | Standard Smoking Cessation | BA for Substance Abusing Smokers | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 32 | 33 | 65 |
| Race (NIH/OMB)(Participants) | Standard Smoking Cessation | BA for Substance Abusing Smokers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 42 | 47 | 89 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Standard Smoking Cessation | BA for Substance Abusing Smokers | Total |
|---|---|---|---|
| United States | 47 | 49 | 96 |
Ran from Dec 2011 to primary completion in May 2015, 41 months.
Results were first posted in Sep 2020, 5 years 4 months after primary completion.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, College Park