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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline + PSF-M for Smoking Cessation in HIV/AIDS
Phase 3
Recruiting
Led By Gina Kruse, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (≥18 years)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post-randomization
Awards & highlights
Study Summary
This trial will test if an intervention combining a mobile program and medication can help people with HIV quit smoking.
Who is the study for?
This trial is for adults over 18 with HIV who smoke tobacco, have a viral load under 1000 copies/mL, and CD4 count above 200 cells/mm3. They must read at a 6th-grade level in Tamil, Telugu or English and can safely use varenicline. Women must agree to contraception during the study.Check my eligibility
What is being tested?
The study tests an intervention to help people with HIV quit smoking using PSF-M (a mobile behavioral program) and Varenicline (a medication). Participants will receive either this combination or standard care to see which helps more with quitting.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep problems, constipation, gas, vomiting. It can also lead to mood changes or trouble driving/operating machinery due to drowsiness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-Day Point Prevalent Abstinence Rate
Secondary outcome measures
7-day self-reported Point Prevalent Abstinence Rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Varenicline + Positively Smoke Free - MobileExperimental Treatment2 Interventions
Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.
Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.
Group II: Standard CareActive Control1 Intervention
Brief advice to quit tobacco Offer of referral to the national tobacco quitline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,101 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,605 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,737 Previous Clinical Trials
2,148,906 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack or unstable chest pain in the last 30 days.My liver enzymes are high or my kidney function is low.You have recently been diagnosed with HIV, your viral load is below 1000 copies/mL and your CD4 count is above 200 cells/mm3.I am 18 years old or older.I have a history of psychosis or am taking anti-psychotic medications.I have major depression that is either untreated or not well-controlled.I am able to understand and consent to the trial on my own.You are a current smoker or dual tobacco user, confirmed by exhaled carbon monoxide of 7 parts per million or higher.You have attempted to take your own life in the past.You are able to read and converse fluently in Tamil, Telugu or English at a minimum of 6th grade competency.I am currently having thoughts about harming myself.You are currently breastfeeding a child.My doctor has approved me to use varenicline safely.I have had liver or kidney failure in the past.You are allergic to varenicline.Women of reproductive age who agree to utilize an accepted form of contraception or desist from sexual activity while consuming the medication studied, and for thirty days after cessation.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline + Positively Smoke Free - Mobile
- Group 2: Standard Care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the U.S. Food and Drug Administration given authorization to Varenicline + Positively Smoke Free - Mobile?
"An assessment of the safety profile for Varenicline + Positively Smoke Free - Mobile scored a 3 due to existing clinical data that supports its efficacy and has demonstrated multiple rounds of evidence in favour of its security."
Answered by AI
Are there any opportunities for volunteers to become involved in this investigation?
"The information made available on clinicaltrials.gov suggests that this particular trial is not actively seeking new patients at the present moment, despite having been initially posted and updated as recently as July 1st 2023 and March 13th 2023 respectively. Fortunately, 846 other medical trials are currently open for enrollment."
Answered by AI
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