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

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brown University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Nicotine

Criteria

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.