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Wellness Intervention for Smoking and HIV ((WISH))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725617
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
University of Delaware
Information provided by (Responsible Party):
MICHAEL A GRANDNER, University of Arizona

Brief Summary:
The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions [weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, liver function tests will be monitored at least monthly, and blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

Condition or disease Intervention/treatment Phase
HIV Sleep Smoking Cessation Cardiovascular Diseases Drug: Varenicline Behavioral: Smoking Cessation Counseling Behavioral: Health Approach 1 to Reduce Smoking Other: Health Approach 2 to Reduce Smoking Not Applicable

Detailed Description:

Cigarette smoking among adults living with HIV (ALHIV) is a significant public health problem, leading to substantial morbidity and mortality in this population. Existing smoking cessation interventions are not sufficient, as success rates are relatively low. Poor sleep is more prevalent among smokers, more prevalent among ALHIV, can be caused by smoking cessation attempts, predicts relapse to former smoking patterns, and represents a parallel pathway to morbidity including increased cardiovascular disease (CVD) among ALHIV. Thus, unhealthy sleep may make smoking cessation more difficult and increase cardiovascular risk and other poor health conditions in ALHIV. The proposed study will supplement an empirically-supported smoking cessation program (8-session, 13-week counseling program with varenicline) with a pre-determined behavioral health approach to reducing smoking intervention developed for smokers. The investigators will test the efficacy of behavioral health approach 1 versus behavioral health approach 2 as an active comparator. The investigators will also explore the impact of smoking cessation and changes in sleep on changes in inflammatory biomarkers of cardiovascular disease risk. Approximately 400 ALHIV treatment seeking smokers who have no history of sleep disorders will be screened (through history, physical examination, laboratory studies and an overnight sleep test) to identify 200 eligible subjects to randomize to Intervention Approach 1 versus Intervention Approach 2. All participants will concurrently receive standard smoking cessation treatment including counseling and 12-weeks of varenicline. Screening and treatment sessions will take place at the University of Arizona's Clinical and Translational Sciences Research Center, which is well equipped with private examination rooms and phlebotomists. Successful smoking cessation will be assessed at end of therapy (13 weeks) and again 6 months later by self reports, carbon monoxide breath test, and urine cotinine, a stringent objective marker of tobacco use. Sleep will be assessed through sleep diaries, questionnaires and actigraphy (activity sensors worn on the wrist). Other markers of CVD risk including lipids, 24 hour blood pressure monitoring, and HgbA1C, and biomarkers (IL-6, hsCRP, TNFalpha,ICAM-1, VCAM-1, sCD14, D-dimer) will be determined at baseline, end of therapy, and 6 months follow up. Cognitive function will be assessed through N-Back (uses images), Psychomotor Vigilance Test (PVT), Abstract Matching (AM), and Matrix Reasoning Task (MRT).

Ultimately, the impact of this work will be to transform clinical guidelines for the treatment of nicotine dependence, as well as to provide insights into mechanisms by which improved sleep enhances tobacco cessation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Varenicline

Arm Intervention/treatment
Active Comparator: Health Intervention Approach 1
Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.
Drug: Varenicline
Standard smoking cessation treatment.

Behavioral: Smoking Cessation Counseling
Standard smoking cessation treatment

Behavioral: Health Approach 1 to Reduce Smoking
Behavioral health intervention option 1

Active Comparator: Health Intervention Approach 2
Subjects randomized into Group 1 will be provided with approach 1, a behavioral health intervention administered by a Clinical Psychologist, in addition to administration of medication (Varenicline), and counseling, during 6 study visits.
Drug: Varenicline
Standard smoking cessation treatment.

Behavioral: Smoking Cessation Counseling
Standard smoking cessation treatment

Other: Health Approach 2 to Reduce Smoking
Behavioral health intervention option 2




Primary Outcome Measures :
  1. Change in smoking cessation [ Time Frame: Change in smoking cessation from baseline to end of 13-week timeline and 6 month follow up ]
    Cessation of smoking determined via self-report and biochemical verification of carbon monoxide breath test and urine cotinine.

  2. Change in sleep duration [ Time Frame: Change in sleep duration from baseline to end of 13-week timeline and 6 month follow up ]
    Amount of sleep per night, assessed with sleep diary and actigraphy


Secondary Outcome Measures :
  1. Change in sleep efficiency [ Time Frame: Change in sleep efficiency from baseline to end of 13-week timeline and 6 month follow up ]
    Amount of sleep per night divided by time in bed, assessed with sleep diary and actigraphy

  2. Change in sleep quality [ Time Frame: Change in sleep quality from baseline to end of 13-week timeline and 6 month follow up ]
    Pittsburgh Sleep Quality Index (PSQI) score. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep. In addition, a total score will be evaluated in addition to the individual items. A score of 5 has been identified as a cutoff for "poor" sleep.

  3. Change in sleep continuity [ Time Frame: Change in sleep continuity from baseline to end of 13-week timeline and 6 month follow up ]
    Sleep latency, wake after sleep onset, awakenings, sleep regularity, sleep timing. Assessed with sleep diary and actigraphy

  4. Change in blood pressure [ Time Frame: Change in blood pressure as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up ]
    Assessment of blood pressure (24 hour blood pressure monitoring) as a marker of Cardiovascular Disease (CVD) risk.

  5. Change in lipids [ Time Frame: Change in lipids as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up ]
    Assessment of lipids as a marker of Cardiovascular Disease (CVD) risk.

  6. Change in HgbA1c [ Time Frame: Change in HgbA1c as a marker of CVD risk from baseline to end of 13-week timeline and 6 month follow up ]
    Assessment of HgbA1c as a marker of Cardiovascular Disease (CVD) risk

  7. Change in inflammatory markers of Cardiovascular Disease (CVD) risk [ Time Frame: Change in inflammatory markers of CVD risk from baseline to end of 13-week timeline and 6 month follow up ]
    Assessment of inflammatory biomarkers, including IL6, CRP, and TNFa,ICAM-1, VCAM-1, sCD14, D-dimer, which will be combined to assess change in inflammatory markers.


Other Outcome Measures:
  1. Mediation of Cognitive Function (Working Memory) on Smoking Cessation [ Time Frame: Change in mediation of working memory on smoking cessation from baseline to end of 13-week timeline and 6 month follow up ]
    Joggle cognitive task (N-Back) to assess the mediation of working memory on smoking cessation.

  2. Mediation of Cognitive Function (Sustained Attention) on Smoking Cessation [ Time Frame: Change in mediation of sustained attention on smoking cessation from baseline to end of 13-week timeline and 6 month follow up ]
    Joggle cognitive task (Psychomotor Vigilance Testing (PVT)) to assess the mediation of sustained attention on smoking cessation.

  3. Mediation of Cognitive Function (Executive Function) on Smoking Cessation [ Time Frame: Change in mediation of executive function on smoking cessation from baseline to end of 13-week timeline and 6 month follow up ]
    Joggle cognitive tasks Digital Symbol Substitution Test (DSST) and Balloon Analog Risk Task (BART) will be assessed together as a measure to evaluate executive function to assess the mediation of executive function on smoking cessation.

  4. Mediation of Affective Function on Smoking Cessation using the Patient Health Questionnaire (PHQ-9) [ Time Frame: Change in mediation of smoking cessation by PHQ-9 score from baseline to end of 13-week timeline and 6 month follow up ]
    Patient Health Questionnaire-9 (PHQ-9) questionnaires, (exploratory studies to evaluate for possible mediation of smoking cessation). PHQ9: The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It is a 9 item self-report tool. A total score is calculated for this tool, with scores ranging from 0-27, with lower scores indicating less depressive symptoms, and higher scores indicating more depressive symptoms.

  5. Mediation of Affective Function on Smoking Cessation using the General Anxiety Disorder scale (GAD-7) [ Time Frame: Change in mediation of smoking cessation by GAD-7 score from baseline to end of 13-week timeline and 6 month follow up ]
    General Anxiety Disorder-7 (GAD-7) questionnaire (exploratory studies to evaluate for possible mediation of smoking cessation). The GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from "Not at all" to "Nearly every day".

  6. Mediation of Affective Function on Smoking Cessation using the Positive and Negative Affect Scales (PANAS) [ Time Frame: Change in meditation of smoking cessation by PANAS score from baseline to end of 13-week timeline and 6 month follow up ]
    Positive and Negative Affect Scales (PANAS) (exploratory studies to evaluate for possible mediation of smoking cessation). PANAS: brief measures that assess both positive and negative emotional experiences. Scores can range from 10-50 for each affect (Positive and Negative). Low scores represent low levels of Positive or Negative Affect and high scores represent high levels of Positive or Negative Affect.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 -75 years;
  • Documented HIV infection;
  • CD4+ T cell count ≥ 200 cells/mm3;
  • On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start;
  • Smoke at least 5 cigarettes/day;
  • Report wanting to quit smoking in the next month;
  • Have no sleep disorders (with the exception of insomnia or mild obstructive sleep apnea (apnea-hypopnea index (AHI) 5-14);
  • Able to communicate in English and provide written informed consent for study procedures;
  • Able to use varenicline safely;
  • Will be residing in the geographic area for at least 10 months;
  • Willing to attend 6 in-person sessions and one 6-month follow up assessment.

Exclusion Criteria:

  • Regular use of chewing tobacco, snuff, cigars, e-cigarettes, unless willing to stop;
  • Current enrollment or plans to enroll in another smoking cessation program or use other smoking cessation products for the duration of the study;
  • Women of childbearing potential who are pregnant, lactating, or likely to become pregnant during the trial and unwilling to use contraception during the study;
  • Unstable alcohol use that precludes reliable study participation as assessed by study physician;
  • Unstable drug use that precludes reliable study participation as assessed by study physician;
  • Unstable mental illness that precludes reliable study participation as assessed by study physician;
  • A history of a suicide attempt within the last two years, and/or current nonspecific suicidal thoughts as defined by the Columbia Suicide Severity Rating Scale;
  • Unstable or untreated moderate or severe depression as assessed by the Center for Epidemiology Studies-Depression (CES-D) scale. A score of ≥ 16 correlates with clinical ratings of depression;
  • Serious or unstable disease within the past 6 months (e.g., cancer, seizure disorder, end-stage liver disease, end-stage renal disease, uncontrolled diabetes, pulmonary disease requiring oxygen);
  • Any prior history of seizure disorder;
  • Unstable cardiac condition (i.e., angina, myocardial infarction, or coronary angioplasty) within the past 6 months or an abnormal EKG;
  • Currently working night/rotating shift and/or use of a sleep medication, or a medication that could influence sleep;
  • Prior history of somnambulism;
  • Use of a sleep medication;
  • Inability to complete any of the study tasks as determined by the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725617


Contacts
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Contact: Manuel Acuna (520) 626-1737 macuna@psychiatry.arizona.edu
Contact: Ryan Weltzer, MS (520) 626-6453 ryanweltzer@arizona.edu

Sponsors and Collaborators
University of Arizona
University of Delaware
Investigators
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Principal Investigator: Elizabeth Connick, MD University of Arizona
Principal Investigator: Michael Grandner, PhD University of Arizona
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Responsible Party: MICHAEL A GRANDNER, Associate Professor, Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT04725617    
Other Study ID Numbers: 2005630160
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MICHAEL A GRANDNER, University of Arizona:
HIV
Sleep
Smoking Cessation
Cardiovascular Diseases
Additional relevant MeSH terms:
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Cardiovascular Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs