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Smoking Cessation for People Living With HIV/AIDS

30 de junio de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

165

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Tolan Park Medical Building

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Phase 1: Standard of Care (A)
Brief counseling and bupropion
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: 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.
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Conductual: 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.
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: Brief Counseling
Participants are provided with brief counseling for smoking cessation.
Conductual: 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.
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Conductual: 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.
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: No additional treatment
No additional treatment will be given.
Experimental: Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
Droga: Bupropion
Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
Otros nombres:
  • Wellbutrin
  • Zyban
  • Clorhidrato de bupropión
Conductual: Monitored support to quit smoking
Brief supportive sessions and monitoring of smoking cessation efforts.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Urinary Cotinine
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Wayne State University

Colaboradores

National Institute on Drug Abuse (NIDA)

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2013

Finalización primaria (Anticipado)

1 de diciembre de 2021

Finalización del estudio (Anticipado)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

8 de octubre de 2013

Primero enviado que cumplió con los criterios de control de calidad

15 de octubre de 2013

Publicado por primera vez (Estimar)

18 de octubre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1R01DA034537-01A1 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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