Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV
  • Opioid Dependence
  • Smoking Cessation
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.Masking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV , who smok...

The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV , who smoke and who are receiving care in a methadone maintenance program in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. The study will be conducted in a methadone maintenance clinic for several reasons. First, smoking rates are shockingly high in this setting, and the need for effective tobacco treatment is enormous. Second, there is great synergy in providing behavioral and pharmacological treatment for smoking cessation interventions to clients who are already receiving a pharmacological intervention (i.e., methadone) with concomitant substance use counseling. Third, people in methadone maintenance come regularly to receive treatment which is likely to enhance smoking cessation treatment follow-up and completion. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO<7 ppm). Additionally, the study will conduct an implementation costs assessment to provide rigorously obtained approximations of total implementation costs of each intervention tested in this trial.

Tracking Information

NCT #
NCT03342027
Collaborators
Not Provided
Investigators
Not Provided