Smoking Cessation for People Living With HIV/AIDS

Wayne State University

Status: Unknown

Conditions: AIDS; Nicotine Dependence; HIV

Treatments: Behavioral: No additional treatment; Behavioral: Monitored support to quit smoking; Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: High-magnitude prize contingency management; Behavioral: Low intensity prize contingency management; Behavioral: Prize contingency management for abstinence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01965405

1R01DA034537-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).

1. Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
2. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
3. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.

Full description

All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.

Participants in Phase 1 will be randomized to one of two brief interventions based on standard of care guidelines (SoC): A) brief counseling and bupropion (SoC); or B) SoC plus brief high-magnitude prize CM (HM-CM). At the end of Phase 1, participants will be classified as responders or non-responders on the basis of smoking reduction/abstinence. All participants will continue to receive bupropion. Non-responders will enter Phase 2a and be randomly assigned to: A) continued counseling and monitoring support to quit smoking (MS); or B) MS plus prize CM for abstinence (MS+CM). Phase 1 responders will be entered into Phase 2b and randomly assigned to: A) no additional treatment (NAT); or B) Continued monitoring and low intensity prize CM (LI-CM). The primary dependent variables will include cotinine and carbon monoxide (CO) levels, and longest duration of abstinence from cigarettes. Seven-day point prevalence will be used to assess outcome at post-treatment, 6-month and 12-month follow-up points.

Participants will be paid $35 for intake and $25 for each follow-up interview, which will occur at post-phase 1, post-phase 2, and 6-months and 12-months after treatment initiation. Some assessments as well as treatment sessions will be recorded to ensure data quality.

Enrollment: 165 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Able to read and understand English
3. Smoke more than 10 cigarettes/day
4. Patient enrolled in the HIV clinic with HIV or AIDS diagnosis

Exclusion criteria

1. Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
2. Are in recovery for pathological gambling (PG)
3. Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
4. Are already participating in other smoking cessation interventions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 6 patient groups

Phase 1: Standard of Care (A)

Experimental group

Description:

Brief counseling and bupropion

Treatment:

Behavioral: Brief Counseling

Drug: Bupropion

Phase 1: Standard of Care (B)

Experimental group

Description:

Brief counseling, bupropion, and brief high-magnitude prize contingency management.

Treatment:

Behavioral: Brief Counseling

Behavioral: High-magnitude prize contingency management

Drug: Bupropion

Phase 2a Non-Responders (A)

Experimental group

Description:

Bupropion, continued counseling, monitored support to quit smoking.

Treatment:

Behavioral: Brief Counseling

Behavioral: Monitored support to quit smoking

Drug: Bupropion

Phase 2a: Non-Responders (B)

Experimental group

Description:

Bupropion, monitored support to quit smoking, prize contingency management for abstinence.

Treatment:

Behavioral: Prize contingency management for abstinence

Behavioral: Monitored support to quit smoking

Drug: Bupropion

Phase 2b: Responders (A)

Experimental group

Description:

Bupropion, no additional treatment.

Treatment:

Behavioral: No additional treatment

Drug: Bupropion

Phase 2b: Responders (B)

Experimental group

Description:

Bupropion, continued monitoring and low intensity prize contingency management.

Treatment:

Behavioral: Monitored support to quit smoking

Behavioral: Low intensity prize contingency management

Drug: Bupropion