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Smoking Cessation for People Living With HIV/AIDS

30 juni 2021 uppdaterad av: David Ledgerwood, Wayne State University

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

165

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48201
        • Tolan Park Medical Building

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Phase 1: Standard of Care (A)
Brief counseling and bupropion
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Experimentell: Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Beteende: 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.
Experimentell: Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Beteende: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Experimentell: Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Beteende: 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.
Experimentell: Phase 2b: Responders (A)
Bupropion, no additional treatment.
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: No additional treatment
No additional treatment will be given.
Experimentell: Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
Läkemedel: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Andra namn:
  • Wellbutrin
  • Zyban
  • Bupropionhydroklorid
Beteende: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Urinary Cotinine
Tidsram: 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)
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.
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)
Longest Duration of Continuous Abstinence
Tidsram: 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)
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).
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)
Seven-Day Point-Prevalence
Tidsram: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
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.
Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
Carbon Monoxide Results
Tidsram: 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)
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.
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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wayne State University

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Utredare

  • Huvudutredare: David Ledgerwood, PhD, Wayne State University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2013

Primärt slutförande (Förväntat)

1 december 2021

Avslutad studie (Förväntat)

1 december 2021

Studieregistreringsdatum

Först inskickad

8 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

15 oktober 2013

Första postat (Uppskatta)

18 oktober 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juli 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1R01DA034537-01A1 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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