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Wellness Intervention for Smoking Cessation in HIV/AIDS ((WISH) Trial)
N/A
Recruiting
Led By Elizabeth Connick, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in mediation of smoking cessation by phq-9 score from baseline to end of 13-week timeline and 6 month follow up
Awards & highlights
(WISH) Trial Summary
This trial tests two approaches to help smokers living with HIV quit smoking, with measures taken at baseline, during, and after quitting.
Who is the study for?
Adults aged 18-75 living with HIV, smoking at least 5 cigarettes a day, and wanting to quit in the next month can join. They must be on stable HIV treatment or not planning to start it soon, have a CD4+ count ≥200 cells/mm3, and commit to attending sessions for 10 months. Pregnant women or those likely to become pregnant who won't use contraception are excluded.Check my eligibility
What is being tested?
The trial is testing two different health approaches aimed at reducing smoking alongside varenicline medication and counseling sessions over 13 weeks. It will compare their effects on quitting smoking, improving sleep quality, and lowering cardiovascular risk in people with HIV.See study design
What are the potential side effects?
While taking varenicline participants may experience changes in liver function and blood pressure; these will be monitored regularly. Other common side effects of varenicline include nausea, sleep problems (insomnia), constipation, gas, and vomiting.
(WISH) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not planning to change my current HIV treatment or start any.
(WISH) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in mediation of smoking cessation by phq-9 score from baseline to end of 13-week timeline and 6 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in mediation of smoking cessation by phq-9 score from baseline to end of 13-week timeline and 6 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sleep duration
Change in smoking cessation
Secondary outcome measures
Change in HgbA1c
Change in blood pressure
Change in inflammatory markers of Cardiovascular Disease (CVD) risk
+4 moreOther outcome measures
Mediation of Affective Function on Smoking Cessation using the General Anxiety Disorder scale (GAD-7)
Mediation of Affective Function on Smoking Cessation using the Patient Health Questionnaire (PHQ-9)
Mediation of Affective Function on Smoking Cessation using the Positive and Negative Affect Scales (PANAS)
+3 more(WISH) Trial Design
2Treatment groups
Active Control
Group I: Health Intervention Approach 1Active Control3 Interventions
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.
Group II: Health Intervention Approach 2Active Control3 Interventions
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.
Find a Location
Who is running the clinical trial?
University of DelawareOTHER
154 Previous Clinical Trials
25,011 Total Patients Enrolled
University of ArizonaLead Sponsor
515 Previous Clinical Trials
148,514 Total Patients Enrolled
Elizabeth Connick, MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
121 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can safely take varenicline tartrate.You have tried to harm yourself in the past two years or are currently having thoughts about hurting yourself.I am able to complete all study tasks.I have not had a seizure in the past year.I want to quit smoking within the next month.I am not taking sleep medications that could affect the study.I am not planning to change my current HIV treatment or start any.I am willing to attend 8 sessions and a follow-up after 6 months.I am not planning to join another quit-smoking program or use quit-smoking products during this study.I haven't had any serious or unstable illnesses in the last 6 months.I haven't had a heart attack or heart surgery in the last 6 months.You smoke at least 5 cigarettes every day.I am between 18 and 75 years old.You have a history of sleepwalking as an adult.I work night shifts or take sleep medication.I am not pregnant, breastfeeding, or planning to become pregnant and will use contraception during the study.You regularly use chewing tobacco, snuff, cigars, or e-cigarettes, unless you are willing to stop using them during the study.I do not have severe sleep disorders, only mild insomnia or sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Health Intervention Approach 1
- Group 2: Health Intervention Approach 2
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially qualify to join this experiment?
"Eligibility criteria for this study necessitate that participants demonstrate symptoms of sleep disorder and are between 18 to 75 years old. A total 200 applicants can be admitted in the trial."
Answered by AI
Are there any age restrictions on participation in this trial?
"The clinical trial has specified that the minimum age for enrollment is 18 years old, while the maximum age cap set by this study is 75."
Answered by AI
What insights have been gleaned from prior experiments utilizing Health Intervention Approach 1?
"Presently, there are 19 trials being conducted to research the efficacy of Health Intervention Approach 1; 2 of these experiments have entered Phase 3. In spite of majority originating from Charleston, South carolina, 30 different medical sites across the nation are researching this potential treatment option."
Answered by AI
Are prospective participants currently eligible for this clinical experimentation?
"Affirmative. According to the info on clinicaltrials.gov, this study is in the process of recruiting volunteers. Published on November 16th 2021 and last amended May 30th 2023, the trial seeks 200 individuals at one research site."
Answered by AI
How many participants are eligible to take part in this clinical trial?
"Affirmative. Clinicaltrials.gov displays that this research project, which was originally advertised on November 16th 2021, is actively seeking participants. 200 individuals are sought to take part in the study from a single medical centre."
Answered by AI
What are the objectives of this investigation?
"This clinical trial's principal objective, observed during a 13-week period and 6 month follow up interval, is to measure the alteration in smoking cessation. Secondary effects of note include changes in sleep duration (as indicated by sleep diary and actigraphy), blood pressure (monitored over 24 hours as an indicator for cardiovascular disease risk) and HgbA1c levels (also used to forecast CVD risks)."
Answered by AI
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