SmokingPhase 1SDATNCT02002858

Smoking Cessation for Depression and Anxiety Treatment

A Phase 1 study testing Nicotine Patch, Depression and Anxiety Smoking Cessation Treatment and Educational-Support Psychotherapy in people with Smoking and Anxiety Disorders, run by University of Houston 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

The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking, Anxiety Disorders, Depression Disorders
What is being tested?: Nicotine Patch, Depression and Anxiety Smoking Cessation Treatment and Educational-Support Psychotherapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Oct 2014to May 2017
Phase: Phase 1
Are there results?: None posted in the registry

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

Ages 18-65 years old
Capable of providing informed consent
Willing to attend all study visits and comply with the protocol
Daily smoker for at least one year
Currently smoke an average of at least 6 cigarettes per day
Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
Elevated anxiety or depression

Who cannot join

Use of other tobacco products
Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
Currently suicidal or high suicide risk
Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
Current or intended participation in a concurrent substance abuse treatment
Current non-nicotine substance dependence
Insufficient command of English to participate in assessment or treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

Anxiety and Health Research Laboratory and Substance Use Treatment Clinic
Houston, Texas, 77201

Other trials in United States

About this study

Official title: Integrated Smoking Cessation Treatment for Emotional Dysregulation

Conditions: Smoking, Anxiety Disorders, Depression Disorders
Being tested: Nicotine Patch, Depression and Anxiety Smoking Cessation Treatment, Educational-Support Psychotherapy
Keywords: smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress
Medical subject headings: Smoking, Anxiety Disorders, Depression, Consciousness Disorders

What participants receive

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

Nicotine PatchDrug
Depression and Anxiety Smoking Cessation TreatmentBehavioural
Also called SDAT
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Educational-Support PsychotherapyBehavioural
Educational-based psychotherapy and standard smoking cessation treatment program

Study groups in NCT02002858
Study group	Role	What they receive
Depression and Anxiety Smoking Cessation Treatment	Experimental	Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies Receives: Drug: Nicotine Patch; Behavioral: Depression and Anxiety Smoking Cessation Treatment
Educational-Support Psychotherapy	Active comparator	Educational-based psychotherapy and standard smoking cessation treatment program Receives: Drug: Nicotine Patch; Behavioral: Educational-Support Psychotherapy

What is being measured

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

Smoking Status using the Timeline Follow-Back Assessment
Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).
Measured: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.

Timeline

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

Oct 2014May 2017

First posted6 Dec 2013 (estimated)
Study startOct 2014
Primary completionNov 2016
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002858
Sponsor's protocol ID: 1R34DA03474101
Other IDs: R34DA034741
Acronym: SDAT
Status last verified: Jul 2017
First submitted: 25 Nov 2013
Last updated: 7 Jul 2017
Results posted: No
Data monitoring committee: Yes

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 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Smoking Cessation Treatment for Emotional Dysregulation
ClinicalTrials.gov ID: NCT02002858
Acronym / sponsor ID: SDAT / 1R34DA03474101
Conditions: Smoking, Anxiety Disorders, Depression Disorders
Keywords: smoking, cessation, anxiety, anxious, depression, depressed, smoker, stress
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of HoustonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Oct 2014
Primary completion: Nov 2016 (actual)
Study completion: May 2017 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

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

Arm	Type	Receives
Depression and Anxiety Smoking Cessation Treatment	Experimental	Drug: Nicotine Patch, Behavioral: Depression and Anxiety Smoking Cessation TreatmentCognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
Educational-Support Psychotherapy	Active comparator	Drug: Nicotine Patch, Behavioral: Educational-Support PsychotherapyEducational-based psychotherapy and standard smoking cessation treatment program

Who may qualify

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

Key inclusion criteria (7 listed)

Ages 18-65 years old
Capable of providing informed consent
Willing to attend all study visits and comply with the protocol
Daily smoker for at least one year
Currently smoke an average of at least 6 cigarettes per day

Key exclusion criteria (8 listed)

Use of other tobacco products
Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
Currently suicidal or high suicide risk
Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression

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
Nicotine Patch	Drug	Depression and Anxiety Smoking Cessation Treatment, Educational-Support Psychotherapy
Depression and Anxiety Smoking Cessation TreatmentAlso: SDATCognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies	Behavioural	Depression and Anxiety Smoking Cessation Treatment
Educational-Support PsychotherapyEducational-based psychotherapy and standard smoking cessation treatment program	Behavioural	Educational-Support Psychotherapy

Primary outcome

Smoking Status using the Timeline Follow-Back Assessment
Time frame: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.
Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.

Related trials for Smoking

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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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.

Michael J Zvolensky, Ph.D. principal investigator

University of Houston

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 7 inclusion and 8 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 7 Jul 2017. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Smoking Status using the Timeline Follow-Back Assessment (time frame: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.). 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 NCT02002858.

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 7 Jul 2017.