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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

Must not have

Any prior history of seizure disorder within the past year

Use of a sleep medication that will interfere with study results

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

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not planning to change my current HIV treatment or start any.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a seizure in the past year.

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I am not taking sleep medications that could affect the study.

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I am not planning to join another quit-smoking program or use quit-smoking products during this study.

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I haven't had any serious or unstable illnesses in the last 6 months.

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I am not pregnant, breastfeeding, or planning to become pregnant and will use contraception during the study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in mediation of smoking cessation by phq-9 score from baseline to end of 13-week timeline and 6 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sleep duration

Change in smoking cessation

Secondary study objectives

Change in HgbA1c

Change in blood pressure

Change in inflammatory markers of Cardiovascular Disease (CVD) risk

+4 more

Other study objectives

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

Awards & Highlights

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.

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

0 / 6Eligibility criteria met