Cognitive Behavioral Therapy for Smoking Cessation in HIV/AIDS

Recruiting at 2 trial locations

Overseen By Samantha M McKetchnie, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Tobacco products, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 9 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).

Who Is on the Research Team?

Jasper Smits, PhD

Principal Investigator

University of Texas at Austin

Michael Zvolensky, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for HIV-positive individuals aged 18-79 who smoke daily and are motivated to quit. They must understand English well enough to give informed consent. People using other tobacco products, undergoing current smoking cessation treatment, or with untreated/unstable psychiatric disorders can't participate.

Inclusion Criteria

HIV-positive

You are willing to stop smoking.

You smoke cigarettes every day.

Exclusion Criteria

I do not have untreated or unstable mental health issues.

You use tobacco products regularly, except for cigarettes.

Insufficient command of the English language

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 9-session, cognitive-behavioral therapy-based intervention for smoking cessation and anxiety/depression management

9 weeks

9 visits (in-person)

Short-Term Follow-up

Participants are monitored for smoking abstinence and changes in anxiety/depression at 1-month post quit day

1 month

Long-Term Follow-up

Participants are monitored for smoking abstinence and changes in anxiety/depression at 6-months post quit day

6 months

What Are the Treatments Tested in This Trial?

Interventions

• QUIT
• Time-Matched Control (TM)

Trial Overview The study tests a cognitive-behavioral-based intervention called QUIT against a Time-Matched Control (TM) to help smokers living with HIV quit by reducing anxiety and depression. It's a fully powered trial aiming to see if the intervention increases abstinence from smoking at 1-month and 6-month follow-ups.

How Is the Trial Designed?

Group I: QUIT Treatment for Smoking Cessation and Distress Tolerance Experimental Treatment 1 Intervention

Participants in this intervention arm will receive a Cognitive-Behavioral therapy-based intervention for smoking cessation in people living with HIV.

Group II: Time and Intensity-Match Control Active Control 1 Intervention

Participants in this control arm will receive an intervention matched in time and intensity with the experimental arm.

Group III: Standard of Care Active Control 1 Intervention

At each clinic, routine assessment of smoking status occurs at least annually for patients receiving care, but prescription for pharmacotherapy for smoking cessation and referral for behavioral smoking cessation services are rare. Patients will receive the standard of care at the clinic they attend. SOC patients will also attend the first session that participants in the other sessions receive (pre-randomization), will come to the clinic for assessment only during the weeks lining up with sessions 6-10 for the other conditions, and receive the transdermal nicotine patch for 8 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Southern Methodist University

Collaborator

Trials

37

Recruited

6,000+

The Fenway Institute

Collaborator

Trials

15

Recruited

2,900+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+