Nicotine DependenceProject QuitNCT01393301
Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
A study testing Integrated cognitive-behavioral therapy for smoking cessation and anxiety in people with Nicotine Dependence and Symptoms of Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Symptoms of Anxiety, HIV
- What is being tested?
- Integrated cognitive-behavioral therapy for smoking cessation and anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2015
- Phase
- Interventional
- 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
- 18-65 years old
- Informed consent
- Daily smoker
- Motivated to quit smoking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence, Symptoms of Anxiety, HIV
- Being tested
- Integrated cognitive-behavioral therapy for smoking cessation and anxiety, Control
- Keywords
- Nicotine dependence, Smoking, cessation, Quitting, Anxiety symptoms, Cognitive-behavioral therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated cognitive-behavioral therapy for smoking cessation and anxietyBehavioural
Also called QUESTT
Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
ControlBehavioural
Also called Enhanced Treatment as Usual (ETAU)
Enhanced standard smoking cessation treatment and NRT.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention Arm | Experimental | Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. Receives: Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety |
| Control Arm | Other | Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Acceptability
Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions.
Qualitative interviews were also conducted with participants at the end of the study.
Measured: 6 months
Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
Measured: 6 months
Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
Measured: 10 weeks
Secondary outcomes (1)
Treatment Related Changes in Psychological Distress.
Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startOct 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Methodist University, University of Houston, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Conall O'Cleirigh, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393301
- Sponsor's protocol ID
- R34DA031038-01A1
- Other IDs
- 1R34DA031038-01A1
- Acronym
- Project Quit
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2011
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PubMed 39101506O'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.
PubMed 30212438
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
- ClinicalTrials.gov ID
- NCT01393301
- Acronym / sponsor ID
- Project Quit / R34DA031038-01A1
- Conditions
- Nicotine Dependence, Symptoms of Anxiety, HIV
- Keywords
- Nicotine dependence, Smoking, cessation, Quitting, Anxiety symptoms, Cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Southern Methodist University, University of Houston, National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention Arm | Experimental | Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxietyStandard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. |
| Control Arm | Other | Behavioral: ControlEnhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- Informed consent
- Daily smoker
- Motivated to quit smoking
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Integrated cognitive-behavioral therapy for smoking cessation and anxietyAlso: QUESTTStandard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. | Behavioural | Behavioral Intervention Arm |
| ControlAlso: Enhanced Treatment as Usual (ETAU)Enhanced standard smoking cessation treatment and NRT. | Behavioural | Control Arm |
Primary outcome
Treatment Acceptability
Time frame: 6 months
Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions. Qualitative interviews were also conducted with participants at the end of the study.
Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Time frame: 6 months
Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
Time frame: 10 weeks
Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.
1 secondary outcome
Treatment Related Changes in Psychological Distress.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39101506Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
- Derived from this study: PubMed 30212438O'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.
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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.
Conall O'Cleirigh, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated cognitive-behavioral therapy for smoking cessation and anxiety in people with Nicotine Dependence and Symptoms of Anxiety, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 4 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 3 May 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). 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?
Treatment Acceptability (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01393301, which also lists 2 linked publications.
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 3 May 2023.