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

Tobacco Use Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994444
• Other study ID #: 2102002917
• Secondary ID: 1R21CA261233-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Brown University
• Contact: Patricia A Cioe, Ph.D.
• Phone: 4018636638
• Email: patricia_cioe[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cigarette smoking is more prevalent in persons with HIV (PWH) in the U.S. when compared with the general population and is linked to increased morbidity and mortality in this population. Furthermore, HIV-positive smokers have increased rates of lung and other smoking-related cancers. Smokers with HIV are a particularly challenging group, often reporting high severity of nicotine dependence and low rates of self-efficacy for quitting, both factors related to poor smoking cessation outcomes. Establishing more effective smoking cessation approaches for smokers with HIV, particularly those that address low self-efficacy and severe dependence, is a public health priority. 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 12-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 on quit date (week 4), consistent with recommended guideline 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, initiated on quit date. Dependence, urge to smoke and self-efficacy for quitting prior to and following quit date will be examined. Differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8 and 12 will also be examined. This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes in PWH. Given the high prevalence of smoking and the significant morbidity associated with it in PWH, the development of effective strategies to reduce the risks related to smoking in this group is critical. If determined to be effective, this intervention could be readily disseminated in HIV clinics. This study will provide key information on the potential benefit of NRT preloading in a population that is highly dependent on nicotine and highly vulnerable to smoking-related morbidity and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• HIV Seropositivity
• Tobacco Use Cessation

Intervention

Drug:
• Nicoderm CQ 21Mg/24Hr Transdermal System
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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to NRT	Percent days used nicotine replacement therapy in past 8 weeks	week 12
Secondary	7 day point prevalence abstinence	no cigarette smoking in past 7 days	week 16