Impact of Cannabis Use and Abstinence on Emotion (ICAE)
30 de julio de 2026 actualizado por: Rick James Macatee, Florida State University
Impact of Cannabis Withdrawal and Early Abstinence on Threat and Reward Processing
The goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are:
Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence from cannabis?
Compared to using cannabis as usual, will threat reactivity be elevated at weeks 1 and 2 of abstinence followed by a decrease at week 3 of abstinence?
Compared to using cannabis as usual, will non-drug reward reactivity be lower at weeks 1 and 2 of abstinence followed by an increase at week 3 of abstinence?
Compared to successful 3-week abstainers, will threat, non-drug reward, and cannabis cue reactivity differ in relapsers?
Researchers will compare females with CUD who abstain from cannabis for three weeks to those who continue to use cannabis as usual to see how cannabis abstinence impacts threat and reward processing.
Participants will:
Be randomly assigned to continue using cannabis as usual or abstain from cannabis for three weeks Visit the lab 6 times over three weeks, followed by a 1-month follow-up lab visit for the participants assigned to the cannabis abstinence condition Complete phone surveys every other day across the three week study period
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
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
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Florida
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Tallahassee, Florida, Estados Unidos, 32304
- The BRAINS Lab in the Department of Psychology at Florida State University
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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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- >=5 cannabis use days per week on average over the past 3 months
- Female
- >=6 past-year CUD symptoms (must include withdrawal and at least one criterion other than craving must be met within the past 3 months)
- >=20 days of cannabis use over the past 30 days
- Positive urinalysis for THC
- Cannabis is primary substance of abuse
Exclusion Criteria:
- Current pregnancy
- History of psychotic, seizure, or cardiovascular disorder
- Immediate plan to quit cannabis
- Current treatment for cannabis use
- Current daily psychotropic medication use
- Lotion allergy
- Positive urinalysis for any drug other than THC
- CSRSS >= 4
- Current moderate (4+ criteria) or severe (6+ criteria) substance use disorder (SUD) other than CUD or nicotine dependence
- CBD use >= 9 days
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Contingency Management for Cannabis Abstinence and Lab Visit Attendance
Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce sustained abstinence from cannabis and attendance at all lab visits.
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Escalating monetary reinforcement is provided for continuous cannabis abstinence and lab visit attendance across the three week study period.
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Otro: Contingency Management for Lab Visit Attendance
Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce attendance at all lab visits.
Participants will continue to use cannabis as usual.
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Escalating monetary reinforcement is provided for lab visit attendance across the three week study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Late Positive Potential
Periodo de tiempo: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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The Late Positive Potential (neural measure recorded via electroencephalography) will be quantified from ~400 to 3000ms at central-parietal sensors relative to the onset of a cannabis, neutral, unpleasant, or pleasant image.
The Late Positive Potential to cannabis vs. neutral and cannabis vs. pleasant will be the primary contrasts of interest.
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Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Reward Positivity
Periodo de tiempo: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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The Reward Positivity (neural measure recorded via electroencephalography) will be quantified from ~200-300ms at frontal-central sensors relative to the onset of monetary win and loss feedback.
The win vs. loss contrast will be the primary outcome of interest.
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Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Eyeblink Startle Response
Periodo de tiempo: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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The Eyeblink Startle Response (recorded via EMG sensors) will be quantified as the peak blink amplitude relative to the onset of an auditory startle probe during blocks with predictable shocks, unpredictable shocks, and no threat of shock.
The Eyeblink Startle Response during unpredictable shock threat vs. no shock threat will be the primary contrast of interest.
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Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Delta Power
Periodo de tiempo: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Delta Power (neural time-frequency measure recorded via electroencephalography) will be quantified as event-related spectral power from 1-3.5Hz at frontal-central sensors relative to the onset of monetary win and loss feedback.
The win vs. loss contrast will be the primary outcome of interest.
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Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Delta Intertrial Phase Coherence
Periodo de tiempo: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Delta Intertrial Phase Coherence (neural time-frequency measure recorded via electroencephalography) will be quantified as intertrial phase coherence of 1-3.5Hz oscillations at frontal-central sensors relative to the onset of monetary win and loss feedback.
The win vs. loss contrast will be the primary outcome of interest.
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Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
24 de enero de 2022
Finalización primaria (Actual)
15 de julio de 2024
Finalización del estudio (Actual)
15 de julio de 2024
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AUIRB#20-217FB
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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