Cigarette SmokingPhase 1/2BA-DASNCT01372254

Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

A Phase 1/2 study testing Standard Treatment, BAD-AS and Transdermal Nicotine Patch in people with Cigarette Smoking and Drug Use, run by University of Maryland, College Park at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cigarette Smoking, Drug Use
What is being tested?: Standard Treatment, BAD-AS and Transdermal Nicotine Patch
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteUnited States
Study dates: Dec 2011to May 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

between 18 and 65 years of age
regular smoker for at least one year
currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day
report motivation to quit smoking in the next month
report elevated depressive symptoms

Who cannot join

physical concerns contraindicating the nicotine patch
limited mental competency and/or the inability to give informed, voluntary, written consent to participate
current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
use of psychotropic medication for < 3 months
primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes)
psychotic symptoms
current pregnancy or plans to become pregnant within the following three months

Trial locations and contacts

1 site in 1 country.

United States1 site

Salvation Army Harbor Light Center
Washington D.C., District of Columbia, 20002

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Cigarette Smoking, Drug Use
Being tested: Standard Treatment, BAD-AS, Transdermal Nicotine Patch
Keywords: Cigarette Smoking, Drug Use, Depressed Mood
Medical subject headings: Cigarette Smoking, Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard TreatmentBehavioural
Also called ST
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.
BAD-ASBehavioural
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.
Transdermal Nicotine PatchDrug
Also called Nicoderm CQ
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.

Study groups in NCT01372254
Study group	Role	What they receive
Standard smoking cessation	Active comparator	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. Receives: Behavioral: Standard Treatment; Drug: Transdermal Nicotine Patch
BA for substance abusing smokers	Experimental	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. Receives: Behavioral: BAD-AS; Drug: Transdermal Nicotine Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
7 days of smoking abstinence confirmed biochemically at 26 weeks
Measured: 26 weeks post quit date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011May 2015

First posted13 Jun 2011 (estimated)
Study startDec 2011
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01372254
Sponsor's protocol ID: RSGT1101101CPPD
Acronym: BA-DAS
Status last verified: May 2022
First submitted: 10 Jun 2011
Last updated: 18 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
ClinicalTrials.gov ID: NCT01372254
Acronym / sponsor ID: BA-DAS / RSGT1101101CPPD
Conditions: Cigarette Smoking, Drug Use
Keywords: Cigarette Smoking, Drug Use, Depressed Mood
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: University of Maryland, College ParkUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: Dec 2011 (actual)
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 13 Jun 2011 (estimated)
Results: Posted 14 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Standard smoking cessation	Active comparator	Behavioral: Standard Treatment, Drug: Transdermal Nicotine PatchParticipants 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.
BA for substance abusing smokers	Experimental	Behavioral: BAD-AS, Drug: Transdermal Nicotine PatchThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

between 18 and 65 years of age
regular smoker for at least one year
currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day
report motivation to quit smoking in the next month
report elevated depressive symptoms

Key exclusion criteria (7 listed)

physical concerns contraindicating the nicotine patch
limited mental competency and/or the inability to give informed, voluntary, written consent to participate
current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
use of psychotropic medication for < 3 months
primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard TreatmentAlso: STParticipants 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.	Behavioural	Standard smoking cessation
BAD-ASThe 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.	Behavioural	BA for substance abusing smokers
Transdermal Nicotine PatchAlso: Nicoderm CQ8 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.	Drug	BA for substance abusing smokers, Standard smoking cessation

Primary outcome

Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
Time frame: 26 weeks post quit date
7 days of smoking abstinence confirmed biochemically at 26 weeks

Results and safety

Results posted to the registry on 14 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Smoking Cessation	47	43
BA for Substance Abusing Smokers	49	46

Primary outcome: Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date

Time frame: 26 weeks post quit date. Count of participants. Unit: Participants

Measure	Standard Smoking Cessation n = 47	BA for Substance Abusing Smokers n = 49
Value	5	1

Adverse events

Time frame: 3 years, 3 months. Adverse events were monitored through study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Smoking Cessation	0 of 47 (0%)	0 of 47 (0%)	1 of 47
BA for Substance Abusing Smokers	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura MacPherson, PhD principal investigator

University of Maryland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date (time frame: 26 weeks post quit date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01372254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.