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Transdiagnostic CBT for Smoking Cessation

N/A
Recruiting
Led By Michael Zvolensky, Ph.D.
Research Sponsored by University of Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Inclusion criteria for the study include 1) being 18-65 years of age, 2) daily smoking of at least 5 cigarettes per day for at least one year and biochemically confirmed at least 10 ppm at baseline. Participants must be 3) motivated to quit smoking in the next month 4) have clinically significant anxiety or depression defined as >=8 on the OASIS or ODIS, 5) must be willing and able to attend all the appointments, and 6) must be willing to quit smoking as the sixth treatment session.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial looks at a new treatment for smokers with anxiety and depression, which could provide a better way to help them quit.

Who is the study for?
This trial is for adults aged 18-65 who smoke at least 5 cigarettes daily for a year, want to quit soon, and have anxiety or depression. They must attend all sessions and agree to quit by the sixth session. It's not suitable for those outside this age range or smoking habit.Check my eligibility
What is being tested?
The study tests a new therapy called UP-ST against standard treatment plus nicotine patches in anxious/depressed smokers. The goal is to see if one protocol can help stop smoking while also addressing emotional issues tied to it.See study design
What are the potential side effects?
Possible side effects may include typical nicotine patch reactions like skin irritation or sleep problems, and psychological effects from therapy such as increased anxiety or emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short- and long-term point prevalence abstinence (PPA).
Secondary outcome measures
Time to first smoking lapse and time to relapse
Tobacco craving
Tobacco dependence
+1 more

Side effects data

From 2012 Phase 4 trial • 44 Patients • NCT01129336
47%
Constipation
33%
Nausea
33%
Neutropenia
27%
Fatigue
27%
Dyspnoea
27%
Vomiting
27%
Diarrhoea
20%
Arthralgia
20%
Oedema peripheral
20%
Myalgia
20%
Neuropathy peripheral
13%
Urinary tract infection
13%
Cough
13%
Upper respiratory tract infection
13%
Bone pain
13%
Asthenia
13%
Mucosal inflammation
13%
Thrombocytopenia
13%
Abdominal pain
13%
Nasopharyngitis
13%
Hypokalaemia
13%
Insomnia
13%
Nasal congestion
13%
Night sweats
13%
Hot flush
7%
Rash
7%
Urine output decreased
7%
Postoperative wound infection
7%
Hypocalcaemia
7%
Radiation skin injury
7%
Tremor
7%
Sleep disorder
7%
Back pain
7%
Sinus headache
7%
Productive cough
7%
Abdominal pain upper
7%
Dysphagia
7%
Anaemia
7%
Vulvovaginal candidiasis
7%
Alopecia
7%
Drug hypersensitivity
7%
Palpitations
7%
Stomatitis
7%
Weight increased
7%
Haemoglobin decreased
7%
Dehydration
7%
Oedema mouth
7%
Rectal haemorrhage
7%
Hyponatraemia
7%
Coagulopathy
7%
Abdominal distension
7%
Leukopenia
7%
Generalised oedema
7%
Deafness
7%
Lip ulceration
7%
Erythema of eyelid
7%
Abdominal discomfort
7%
Chest pain
7%
Jaundice
7%
Acute sinusitis
7%
Cellulitis
7%
Hypoalbuminaemia
7%
Platelet count decreased
7%
Hypochloraemia
7%
Musculoskeletal pain
7%
Pain in jaw
7%
Dizziness
7%
Bladder irritation
7%
Muscular weakness
7%
Headache
7%
Pain in extremity
7%
Wheezing
7%
Joint swelling
7%
Dyspnoea paroxysmal nocturnal
7%
Musculoskeletal chest pain
7%
Dysphonia
7%
Dermatitis contact
7%
Orthopnoea
7%
Dysgeusia
7%
Depression
7%
Oropharyngeal pain
7%
Hyperhidrosis
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Plantar erythema
7%
Lymphoedema
7%
Skin exfoliation
7%
Hypertension
7%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Without Bone Metastases
Patients With Bone Metastases

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Control- StandardExperimental Treatment1 Intervention
The Intervention will be the standard therapy sessions. Participants will receive a standard smoking cessation treatment based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence19. The investigative team has considerable expertise in developing and evaluating behavioral and pharmacological treatments for smoking cessation. Treatment will be delivered in eight, 90-minute sessions over an eight-week period.
Group II: Active- UP-STActive Control2 Interventions
The intervention will be the UP-ST therapy sessions. Treatment will be delivered using the new UP-ST protocol that will be developed in Phase I by integrating components of smoking cessation treatments (e.g. using the nicotine patch) with the theoretical model and treatment components of the existing UP treatment protocol, which includes both a therapist14 and patient12 manual. The UP-ST will maintain the same focus on transdiagnostic mechanisms of change as in the original UP, but will be adapted to integrate the smoking cessation focus and concurrent use of NRT. Thus, the investigators can successfully adapt and develop the new UP-ST to be delivered in eight 90-minute sessions and will be able to incorporate content from each of the 8 modules of the UP in the new UP-ST protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Therapy
2007
Completed Phase 4
~16800

Find a Location

Who is running the clinical trial?

University of HoustonLead Sponsor
147 Previous Clinical Trials
47,482 Total Patients Enrolled
Matthew Gallagher, Ph.D.Study DirectorUniversity of Houston
Michael Zvolensky, Ph.D.Principal InvestigatorUniversity of Houston
1 Previous Clinical Trials
115 Total Patients Enrolled

Media Library

Standard Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03920137 — N/A
Smoking Cessation Research Study Groups: Active- UP-ST, Control- Standard
Smoking Cessation Clinical Trial 2023: Standard Therapy Highlights & Side Effects. Trial Name: NCT03920137 — N/A
Standard Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03920137 — N/A
Smoking Cessation Patient Testimony for trial: Trial Name: NCT03920137 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to participate in this scientific experiment at the moment?

"As per entries found on clinicaltrials.gov, this research trial is currently in search of participants. The study was first advertised on December 20th 2020 and the listing has most recently been updated on April 10th 2021."

Answered by AI

Does this clinical experiment accept participants aged 55 and above?

"This clinical trial is exclusive to patients aged 18-65. Interestingly, there are 182 studies specifically for minors and 1014 trials that cater exclusively to seniors."

Answered by AI

Is there a specific criteria for participants to be qualified in this research?

"In order to qualify for this clinical trial, an applicant must have quit smoking and be aged between 18-65. 70 candidates in total are needed for the study."

Answered by AI

How many individuals have been enrolled in this clinical investigation?

"Affirmative. As per information on clinicaltrials.gov, this research is in the process of recruiting participants. It was initially posted on December 20th 2020 and has recently been modified as of April 10th 2021 with a goal to sign up 70 patients from one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've been trying to quit but I can't One pack per day. Taking Lorazepam for anxiety.
PatientReceived 2+ prior treatments
I have tried to quit smoking a few times with no success.I am willing to try something different.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How much is the compensation?
PatientReceived no prior treatments
Recent research and studies
American Journal of EpidemiologyJournal
The 2014 Surgeon General's Report: Commemorating the 50th Anniversary of the 1964 Report of the Advisory Committee to the US Surgeon General and Updating the Evidence on the Health Consequences of Cigarette Smoking
Alberg, A. J., D. R. Shopland, and K. M. Cummings. 2014. “The 2014 Surgeon General's Report: Commemorating the 50th Anniversary of the 1964 Report of the Advisory Committee to the US Surgeon General and Updating the Evidence on the Health Consequences of Cigarette Smoking”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/aje/kwt335.
clinicaltrials.govStudy
Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers
Michael J. Zvolensky, Ph.D. 2020. "Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03920137.
~16 spots leftby Apr 2025
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