Patch Study - Intervention for HIV Positive Smokers

NCT ID: NCT02982772

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-05-31

Brief Summary

The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. To test researchers proposed model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines + nicotine replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day.

Detailed Description

The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these excessive levels will enhance the efficacy of the intervention. This will be accomplished by assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge has not been used in cessation studies among people living with HIV (PLWH), and 3) providing tailored feedback to the participants, based on the assumption that the higher the knowledge and perception of risk, the higher the interest in modifying a risky behavior(s). To test researchers proposed model based in proven smoking prevention and control methods 600 PLWH ready to quit smokers will be enrolled in a double-blind randomized clinical trial intent-to-treat design, comparing a standard well-validated brief smoking intervention, that following national guidelines will consist on brief advice + nicotine replacement therapy, versus the tailored one (brief smoking intervention + personalized doses of nicotine replacement therapy (NRT). The primary outcome for this study will be rates of smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the potential to provide a more complete bio-behavioral model to the intervention field. The proposed study if successful will provide a new tailored, replicable, and manual-based intervention for people living with HIV. It can also provide much need it information in regards to key mediators and moderators of smoking cessation interventions in this vulnerable population. Researchers long term goal is to reduce the burden of one of the most devastating causes of morbi-mortality in researchers time and improve their quality of life. The study could also pave the path to use a similar model to tailor smoking interventions for other populations (e.g., menthol users, older women, adolescents, older adults).

Conditions

Smoking Cessation; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tailored Combination Therapy

Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.

Doses will be tailored and adjust as need it

Group Type: EXPERIMENTAL

Combination Therapy

Intervention Type: OTHER

Brief behavioral intervention

The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.

Standard Care Intervention

Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.

Standard Flavored gums will be used as needed for 10 weeks.

Group Type: ACTIVE_COMPARATOR

Standard Care Intervention

Intervention Type: OTHER

Brief Behavioral Intervention

The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.

Standard Flavored Gums for 10 weeks

Interventions

Combination Therapy

Brief behavioral intervention

The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.

Intervention Type: OTHER

Standard Care Intervention

Brief Behavioral Intervention

The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.

Standard Flavored Gums for 10 weeks

Intervention Type: OTHER

Other Intervention Names

Nicoderm, Nicorette

Eligibility Criteria

Inclusion Criteria

• HIV infected smokers
• 18 years of age and older
• Fluent in English or Spanish
• Able to consent
• Ready to quit smoking

Exclusion Criteria

• Psychotic or disabling psychiatric disorders
• Six months post-myocardial infarction or stroke
• Diabetes requiring insulin
• Treatment for vascular problems
• Non-treated hypertension,
• Severe liver or kidney disease
• History of allergies to the nicotine patches
• Severe eczema or psoriasis
• Temporal-mandibular joint disease or dental appliances
• Pregnant women or women that are breastfeeding
• Subjects participating in other interventions/research

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

dr. maria miguez

OTHER

Sponsor Role: lead

Responsible Party

dr. maria miguez

Research Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maria Jose Miguez, MD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Guillermo Castro, MD

Role: STUDY_DIRECTOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FloridaIU

Identifier Type: -

Identifier Source: org_study_id