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Smoking Cessation for People Living With HIV/AIDS

Primary Purpose

HIV, AIDS, Nicotine Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Brief Counseling
High-magnitude prize contingency management
Monitored support to quit smoking
No additional treatment
Prize contingency management for abstinence
Low intensity prize contingency management
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, AIDS, Nicotine Dependence, Smoking, Smoking cessation, Contingency Management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tolan Park Medical Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1: Standard of Care (A)

Phase 1: Standard of Care (B)

Phase 2a Non-Responders (A)

Phase 2a: Non-Responders (B)

Phase 2b: Responders (A)

Phase 2b: Responders (B)

Arm Description

Brief counseling and bupropion

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

Bupropion, continued counseling, monitored support to quit smoking.

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

Bupropion, no additional treatment.

Bupropion, continued monitoring and low intensity prize contingency management.

Outcomes

Primary Outcome Measures

Urinary Cotinine
Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.
Longest Duration of Continuous Abstinence
This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
Seven-Day Point-Prevalence
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.
Carbon Monoxide Results
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2013
Last Updated
June 30, 2021
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01965405
Brief Title
Smoking Cessation for People Living With HIV/AIDS
Official Title
Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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). Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone. 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. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Nicotine Dependence
Keywords
HIV, AIDS, Nicotine Dependence, Smoking, Smoking cessation, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Standard of Care (A)
Arm Type
Experimental
Arm Description
Brief counseling and bupropion
Arm Title
Phase 1: Standard of Care (B)
Arm Type
Experimental
Arm Description
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Arm Title
Phase 2a Non-Responders (A)
Arm Type
Experimental
Arm Description
Bupropion, continued counseling, monitored support to quit smoking.
Arm Title
Phase 2a: Non-Responders (B)
Arm Type
Experimental
Arm Description
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Arm Title
Phase 2b: Responders (A)
Arm Type
Experimental
Arm Description
Bupropion, no additional treatment.
Arm Title
Phase 2b: Responders (B)
Arm Type
Experimental
Arm Description
Bupropion, continued monitoring and low intensity prize contingency management.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Bupropion hydrochloride, Wellbutrin, Zyban
Intervention Description
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Intervention Type
Behavioral
Intervention Name(s)
Brief Counseling
Intervention Description
Participants are provided with brief counseling for smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
High-magnitude prize contingency management
Intervention Description
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Intervention Type
Behavioral
Intervention Name(s)
Monitored support to quit smoking
Intervention Description
Brief supportive sessions and monitoring of smoking cessation efforts.
Intervention Type
Behavioral
Intervention Name(s)
No additional treatment
Intervention Description
No additional treatment will be given.
Intervention Type
Behavioral
Intervention Name(s)
Prize contingency management for abstinence
Intervention Description
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Intervention Type
Behavioral
Intervention Name(s)
Low intensity prize contingency management
Intervention Description
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
Primary Outcome Measure Information:
Title
Urinary Cotinine
Description
Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.
Time Frame
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
Title
Longest Duration of Continuous Abstinence
Description
This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
Time Frame
Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
Title
Seven-Day Point-Prevalence
Description
At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.
Time Frame
Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
Title
Carbon Monoxide Results
Description
Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.
Time Frame
Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Able to read and understand English Smoke more than 10 cigarettes/day Patient enrolled in the HIV clinic with HIV or AIDS diagnosis Exclusion Criteria: Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care Are in recovery for pathological gambling (PG) 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) Are already participating in other smoking cessation interventions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ledgerwood, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tolan Park Medical Building
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Smoking Cessation for People Living With HIV/AIDS

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