Patch Study - Intervention for HIV Positive Smokers

NCT02982772 | Completed Results DMC

• 1 other identifier: FloridaIU
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; HIV

Keywords

Nicotine Replacement; Smoking; HIV

Outcome Measures

Primary Outcomes (3)

• Rates of Smoking Cessation

  verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).

  3 months

• Rates of Smoking Cessation

  verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).

  6 months

• Rates of Smoking Cessation

  verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).

  12 months

Secondary Outcomes (7)

• Change in Clinical Outcomes

  6 months

• Number of Participants With Verified Continuous Abstinence

  3 months

• Prevalence of Side Effects-safety

  Baseline-6 months

• Change in Clinical Outcomes

  12 months

• Number of Participants With Verified Continuous Abstinence

  6 months

Study Arms (2)

Tailored Combination Therapy

EXPERIMENTAL

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

Other: Combination Therapy

Standard Care Intervention

ACTIVE COMPARATOR

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.

Other: Standard Care Intervention

Interventions

Combination Therapy 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.

Also known as: Nicoderm, Nicorette

Tailored Combination Therapy

Standard Care Intervention 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

Standard Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• dr. maria miguez: lead
• University of Miami: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Combined Modality Therapy; Nicotine; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Please note that verification of quitting was done in all participants before the pandemic. However, during the pandemic the follow up visits were not in person.

Results Point of Contact

• Title: Maria Jose Miguez
• Organization: Florida International University

mjmiguez@fiu.edu

561-839-0223

Study Officials

• Maria Jose Miguez, MD

  Florida International University

  PRINCIPAL INVESTIGATOR

• Guillermo Castro, MD

  University of Miami

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: December 5, 2016
• Study Start: May 1, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 6, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available only after two years of study completion
• Access Criteria: Requires full disclosure of aims and hypothesis Approval by the center and the IRB committees Signing a limited use agreement

Locations

US (1)