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Behavioural Intervention
Integrative Smoking Cessation for HIV Patients
Phase 4
Recruiting
Led By Taghrid A. Asfar, MD, MSPH
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 22 weeks
Awards & highlights
Study Summary
This trial will test if a combined smoking cessation intervention that uses rewards and mindfulness training is more effective than other interventions in helping HIV patients quit smoking.
Who is the study for?
This trial is for adults over 18 with HIV who smoke at least 5 cigarettes a day, want to quit in the next month, own a smartphone, and aren't planning any major life changes soon. It's not for those with recent heart issues, skin disorders related to nicotine patches, current treatment for addiction or serious mental health conditions.Check my eligibility
What is being tested?
The study tests if combining rewards-based strategies (contingency management) with Mindfulness training helps HIV patients stop smoking more effectively than other methods. Participants will use these techniques along with Nicotine Replacement Therapy as part of the cessation program.See study design
What are the potential side effects?
Potential side effects may include irritation from nicotine patches used in replacement therapy and stress or discomfort that can sometimes accompany mindfulness practices or quitting smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 22 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 22 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants reporting 7-day point-prevalence abstinence
Secondary outcome measures
Average enrollment time
Number of completed study measures
Number of enrolled participants
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: MT plus NRT with additional CM GroupExperimental Treatment3 Interventions
Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
Group II: MT plus NRT GroupExperimental Treatment2 Interventions
Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
Group III: CM plus NRT with additional MT GroupExperimental Treatment3 Interventions
Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
Group IV: CM plus NRT GroupExperimental Treatment2 Interventions
Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement Therapy
2019
Completed Phase 4
~8790
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
912 Previous Clinical Trials
411,398 Total Patients Enrolled
Taghrid A. Asfar, MD, MSPHPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing to try to quit smoking within the next month.You are pregnant.You have smoked at least 5 cigarettes per day during the last year.You are currently undergoing treatment to quit smoking, stop alcoholism, or recover from drug addiction.You are under 18 years old.You are currently receiving treatment for a mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: MT plus NRT with additional CM Group
- Group 2: CM plus NRT Group
- Group 3: CM plus NRT with additional MT Group
- Group 4: MT plus NRT Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT05030766 — Phase 4
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