Smoking Cessation for People Living With HIV/AIDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Wayne State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Ledgerwood, Wayne State University
ClinicalTrials.gov Identifier:
NCT01965405
First received: October 8, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
HIV
AIDS
Nicotine Dependence
Drug: Bupropion
Behavioral: Brief Counseling
Behavioral: High-magnitude prize contingency management
Behavioral: Monitored support to quit smoking
Behavioral: No additional treatment
Behavioral: Prize contingency management for abstinence
Behavioral: Low intensity prize contingency management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Urinary Cotinine [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation. ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1: Standard of Care (A)
Brief counseling and bupropion
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Experimental: Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Behavioral: High-magnitude prize contingency management
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.
Experimental: Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Behavioral: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Experimental: Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Behavioral: Prize contingency management for abstinence
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.
Experimental: Phase 2b: Responders (A)
Bupropion, no additional treatment.
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: No additional treatment
No additional treatment will be given.
Experimental: Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
Drug: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Other Names:
  • Bupropion hydrochloride
  • Wellbutrin
  • Zyban
Behavioral: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Behavioral: Low intensity prize contingency management
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965405

Contacts
Contact: Lisa Sulkowski, BS lsulkows@med.wayne.edu

Locations
United States, Michigan
Tolan Park Medical Building Recruiting
Detroit, Michigan, United States, 48201
Contact: Hayley Devoli       hdevoli@med.wayne.edu   
Principal Investigator: David Ledgerwood, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: David Ledgerwood, PhD Wayne State University
  More Information

No publications provided

Responsible Party: David Ledgerwood, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01965405     History of Changes
Other Study ID Numbers: 1R01- DA034537-01A1, 1R01DA034537-01A1
Study First Received: October 8, 2013
Last Updated: March 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Wayne State University:
HIV
AIDS
Nicotine Dependence
Smoking
Smoking cessation
Contingency Management

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014