Clinical trial NCT01393301: Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Official title: Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Symptoms of Anxiety
HIV
Keywords: Nicotine dependence
Smoking, cessation
Quitting
Anxiety symptoms
Cognitive-behavioral therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Southern Methodist University
name: University of Houston
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.

Detailed description: This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The 1-year formative phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be conducted with a small group of individuals (N = up to 12). This phase will be used to establish feasibility of treatment delivery, and participant acceptability before conducting a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes for this trial will be to determine the acceptability and feasibility of the intervention and the potential for an effect on increasing point prevalence abstinence and deceasing psychological distress.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Informed consent
* Daily smoker
* Motivated to quit smoking

Exclusion Criteria:

* Use of other tobacco products
* Untreated or unstable psychiatric disorders
* Current use of cognitive-behavioral therapy or medication for smoking cessation treatment
* Insufficient command of English

Primary outcomes:
measure: Treatment Acceptability
timeFrame: 6 months
measure: Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
timeFrame: 6 months
measure: Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
timeFrame: 10 weeks
Secondary outcomes:
measure: Treatment Related Changes in Psychological Distress.
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Conall O'Cleirigh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Cleirigh C, Zvolensky MJ, Smits JAJ, Labbe AK, Coleman JN, Wilner JG, Stanton AM, Gonzalez A, Garey L, Regenauer KS, Rosenfield D. Integrated Treatment for Smoking Cessation, Anxiety, and Depressed Mood in People Living With HIV: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Oct 1;79(2):261-268. doi: 10.1097/QAI.0000000000001787.