Smoking Cessation for People Living With HIV/AIDS
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, HIV / AIDS, HIV / AIDS, Tobacco Consumers |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/27/2019 |
| Start Date: | August 2013 |
| End Date: | December 2019 |
| Contact: | Lisa Sulkowski, BS |
| Email: | lsulkows@med.wayne.edu |
Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
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.
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.
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.
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.
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.
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