Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts

NCT04994444 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 21020029171R21CA261233-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.

Conditions

Tobacco Use Cessation

Keywords

smoking; HIV; Cessation

Outcome Measures

Primary Outcomes (1)

• Adherence to NRT

  Number of days of nicotine patch use during the 8 weeks of provision

  week 12

Secondary Outcomes (1)

• 7 Day Point Prevalence Abstinence

  week 16

Study Arms (2)

Preloading

EXPERIMENTAL

Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.

Drug: Nicoderm CQ 21Mg/24Hr Transdermal System

Standard treatment

ACTIVE COMPARATOR

Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.

Drug: Nicoderm CQ 21Mg/24Hr Transdermal System

Interventions

Nicoderm CQ 21Mg/24Hr Transdermal System DRUG

Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.

Also known as: Nicotine replacement therapy

Preloading; Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with HIV
• at least 18 years of age
• smoking at least 5 cigarettes/day
• exhaled Carbon Monoxide level greater than 5 at baseline
• willing to use transdermal nicotine patch
• ready to quit in the next 30 days.

You may not qualify if:

• currently using pharmacotherapy for smoking cessation
• medically or psychiatrically unstable (defined as: uncontrolled hypertension, unstable angina, or a medical or psychiatric hospitalization in the 30 days prior to enrollment) \*experiencing psychotic symptoms
• endorsing suicidal ideation upon screening or past-year suicide attempt
• pregnant or nursing.

Sponsors & Collaborators

• Brown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking

Interventions

Nicotine; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Patricia Cioe
• Organization: Brown University

patricia_cioe@brown.edu

4018636638

Study Officials

• Patricia Cioe, PhD

  Brown University School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Research Assistant collecting data at assessment sessions will not be aware of the participant's study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: September 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)