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[Ensayo de dispositivo que no está aprobado o autorizado por la FDA de EE. UU.]

22 de junio de 2026 actualizado por: Joy Schmitz, The University of Texas Health Science Center, Houston

[Ensayo de un dispositivo que no está aprobado o autorizado por la FDA de EE. UU.]

The purpose of this study is to evaluate the effects of Contingency Management (CM)+transcranial magnetic stimulation (TMS) on treatment outcomes in individuals who are initial non-responders and to evaluate the effects of CM+TMS on putative mechanisms of change

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • The University of Texas Health Science Center at Houston
        • Contacto:
        • Contacto:

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
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Able to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study.
  • Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for moderate-to-severe CUD and report recent cocaine use (verified by at least one positive urine drug screen (UDS) for the cocaine metabolite benzoylecgonine (BE), during intake).
  • Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy).

Acceptable contraceptives include:

  1. oral contraceptives
  2. contraceptive sponge
  3. patch
  4. double barrier (diaphragm/spermicidal or condom/spermicidal)
  5. intrauterine contraceptive system
  6. etonogestrel implant
  7. medroxyprogesterone acetate contraceptive injection
  8. complete abstinence from sexual intercourse
  9. hormonal vaginal ring

Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.

  • Women of child-bearing potential must provide negative urine pregnancy test prior to randomization.
  • Be able to provide the names and contact information of at least 2 persons who can consistently locate their whereabouts

Exclusion Criteria:

  • Current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, cannabis, or nicotine or a substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)
  • Presence of any medical, neurological, psychiatric, or physical condition, disease, or illness (including psychosis and bipolar disorder) that, in the opinion of the PIs and the Certified Registered Nurse Anesthetist (CNRA)Medical Director could: (a) compromise interfere, limit, or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data.
  • Has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments:

    1. Structured Clinical Interview for DSM-5 (SCID-5)
    2. Columbia-Suicide Severity Rating Scale - Answers YES to Questions 3, 4, 5, or 6
    3. Assault & Homicidal Danger Assessment Tool - Key to Danger > 1
  • Any contraindications to MRI scans (metal in the body; claustrophobia). -Medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps, electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil).
  • History of brain surgery.
  • History of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
  • Moderate-to-severe heart disease.
  • History of stroke.
  • Taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the study physician; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:

    1. clozapine
    2. chlorpromazine
    3. bupropion
    4. clomipramine hydrochloride
    5. amoxapine
    6. maprotiline hydrochloride
    7. diphenhydramine
    8. stimulants other than cocaine including the following:
    9. Dextroamphetamine and amphetamine ii. Dextroamphetamine iii. Lisdexamfetamine dimesylate iv. Methamphetamine

    v. Methylphenidate i. tramadol j. isoniazid.

  • Personal history of epilepsy or seizure disorder and/or family history including a first degree relative
  • Serious head injury with loss of consciousness
  • Having conditions of probation or parole requiring reports of drug use to officers of the court or impending incarceration
  • For adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturition, or posture).
  • Pregnant or nursing for female participants
  • Inability to read, write, or speak English.

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CM for 2 weeks then CM only
Participants will have thrice-weekly (Monday, Wednesday and Friday) clinic visits, during which participants can earn rewards for submitting a cocaine-negative UDS.CM sessions will consist of the following components: 1) brief discussion of any substance use/cravings since prior CM session; 2) verification that the target behavior (abstinence) was achieved; 3) if achieved, provide incentives and discuss individual plans to use the earnings; 4) if not achieved, review the goals of CM and plans to continue engaging in treatment.
Comparador falso: CM for 2 weeks, then TMS sham plus CM
Participants will have thrice-weekly (Monday, Wednesday and Friday) clinic visits, during which participants can earn rewards for submitting a cocaine-negative UDS.CM sessions will consist of the following components: 1) brief discussion of any substance use/cravings since prior CM session; 2) verification that the target behavior (abstinence) was achieved; 3) if achieved, provide incentives and discuss individual plans to use the earnings; 4) if not achieved, review the goals of CM and plans to continue engaging in treatment.
The sham stimulations with negligible induced electric fields, delivered via the same H4 coil to mimic the acoustic characteristics and scalp sensations of active H4 will be used.
Experimental: CM for 2 weeks, then TMS experimental plus CM

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants who test negative for cocaine use as assessed by urine drug screen
Periodo de tiempo: from Baseline to Week 11
this will be measured measured 3 times per week throughout the study
from Baseline to Week 11
Cocaine craving as assessed by cocaine craving questionnaire (CCQ)
Periodo de tiempo: from Baseline to Week 11
this will be administered weekly. This is a 45 item questionnaire and each is scored on a Likert scale from 1( strongly disagree), to 7(strongly agree). Score range is 45 (minimum) - 315 (maximum).Higher scores indicate greater cocaine craving.
from Baseline to Week 11

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Cue-induced craving as assessed by VAS during cue task
Periodo de tiempo: Baseline, Week 2, Week 11
Cue-induced craving will be assessed with a 100-pt Visual Analogue Scale (VAS) that will ask "How much are you craving cocaine right now?" before and after exposure to an EEG Picture Viewing Task that will display cocaine, emotional, and neutral images. Higher score indicates more craving.
Baseline, Week 2, Week 11
Change in amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG
Periodo de tiempo: Baseline, Week 2, Week 11
The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.
Baseline, Week 2, Week 11
Change in Functional Connectivity between the Bilateral anterior insula (AIn) and central amygdala (CeA) as measured by Functional Magnetic Resonance Imaging (fMRI)
Periodo de tiempo: Baseline, Week 2, Week 11
Functional connectivity between bilateral anterior insula and central amygdala regions will be quantified using resting-state functional magnetic resonance imaging and seed-based connectivity analysis.
Baseline, Week 2, Week 11
Change in Phenotype assessment battery (PhAB) as assessed by addiction domains of cognition, reward, and negative emotionality
Periodo de tiempo: Baseline, Week 2, Week 11
The Phenotype Assessment Battery (PhAB) assesses addiction-related domains including cognition, reward processing, and negative emotionality using a standardized battery of behavioral tasks and self-report measures. Individual measure scores are calculated according to established scoring procedures and converted to standardized scores. Standardized scores within each domain are combined to generate domain-specific composite scores. Composite scores are continuous measures without a fixed range, with higher scores indicating greater impairment within the respective domain.
Baseline, Week 2, Week 11

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Joy M Schmitz, PhD, The University of Texas Health Science Center, Houston

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)

21 de abril de 2026

Finalización primaria (Estimado)

1 de junio de 2029

Finalización del estudio (Estimado)

1 de septiembre de 2029

Fechas de registro del estudio

Enviado por primera vez

18 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de marzo de 2026

Publicado por primera vez (Actual)

24 de marzo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2026

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

22 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HSC-MS-25-0782
  • 1U01DA064181-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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.

Sí

producto fabricado y exportado desde los EE. UU.

No

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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