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[Estudo de dispositivo que não é aprovado ou autorizado pela FDA dos EUA]

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

[Ensaio de dispositivo que não é aprovado ou autorizado pela FDA dos EUA]

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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of participants who test negative for cocaine use as assessed by urine drug screen
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Cue-induced craving as assessed by VAS during cue task
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de abril de 2026

Conclusão Primária (Estimado)

1 de junho de 2029

Conclusão do estudo (Estimado)

1 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

18 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de março de 2026

Primeira postagem (Real)

24 de março de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HSC-MS-25-0782
  • 1U01DA064181-01 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .