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Smoking Cessation for People Living With HIV/AIDS

30 juin 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

165

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Detroit, Michigan, États-Unis, 48201
        • Tolan Park Medical Building

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Phase 1: Standard of Care (A)
Brief counseling and bupropion
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Expérimental: Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Comportemental: 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.
Expérimental: Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Comportemental: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Expérimental: Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Comportemental: 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.
Expérimental: Phase 2b: Responders (A)
Bupropion, no additional treatment.
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: No additional treatment
No additional treatment will be given.
Expérimental: Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
Médicament: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Autres noms:
  • Wellbutrine
  • Zyban
  • Chlorhydrate de bupropion
Comportemental: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Urinary Cotinine
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wayne State University

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: David Ledgerwood, PhD, Wayne State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2013

Achèvement primaire (Anticipé)

1 décembre 2021

Achèvement de l'étude (Anticipé)

1 décembre 2021

Dates d'inscription aux études

Première soumission

8 octobre 2013

Première soumission répondant aux critères de contrôle qualité

15 octobre 2013

Première publication (Estimation)

18 octobre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juin 2021

Dernière vérification

1 juin 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1R01DA034537-01A1 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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