- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07490600
[Estudo de dispositivo que não é aprovado ou autorizado pela FDA dos EUA]
[Ensaio de dispositivo que não é aprovado ou autorizado pela FDA dos EUA]
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Joy M Schmitz, PhD
- Número de telefone: (713) 486-2867
- E-mail: Joy.M.Schmitz@uth.tmc.edu
Estude backup de contato
- Nome: Jessica Vincent
- Número de telefone: 713 486 2803
- E-mail: Jessica.N.Vincent@uth.tmc.edu
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77030
- Recrutamento
- The University of Texas Health Science Center at Houston
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Contato:
- Joy M Schmitz, PhD
- Número de telefone: (713) 486-2867
- E-mail: Joy.M.Schmitz@uth.tmc.edu
-
Contato:
- Jessica Vincent
- Número de telefone: 713 486 2803
- E-mail: Jessica.N.Vincent@uth.tmc.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
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:
- oral contraceptives
- contraceptive sponge
- patch
- double barrier (diaphragm/spermicidal or condom/spermicidal)
- intrauterine contraceptive system
- etonogestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
- 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:
- Structured Clinical Interview for DSM-5 (SCID-5)
- Columbia-Suicide Severity Rating Scale - Answers YES to Questions 3, 4, 5, or 6
- 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:
- clozapine
- chlorpromazine
- bupropion
- clomipramine hydrochloride
- amoxapine
- maprotiline hydrochloride
- diphenhydramine
- stimulants other than cocaine including the following:
- 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
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 |
|---|---|
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Experimental: CM for 2 weeks then CM only
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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.
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Comparador Falso: CM for 2 weeks, then TMS sham plus CM
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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.
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Experimental: CM for 2 weeks, then TMS experimental plus CM
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants who test negative for cocaine use as assessed by urine drug screen
Prazo: from Baseline to Week 11
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this will be measured measured 3 times per week throughout the study
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from Baseline to Week 11
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Cocaine craving as assessed by cocaine craving questionnaire (CCQ)
Prazo: from Baseline to Week 11
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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.
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from Baseline to Week 11
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Cue-induced craving as assessed by VAS during cue task
Prazo: Baseline, Week 2, Week 11
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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.
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Baseline, Week 2, Week 11
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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
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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.
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Baseline, Week 2, Week 11
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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
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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.
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Baseline, Week 2, Week 11
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Change in Phenotype assessment battery (PhAB) as assessed by addiction domains of cognition, reward, and negative emotionality
Prazo: Baseline, Week 2, Week 11
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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.
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Baseline, Week 2, Week 11
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Joy M Schmitz, PhD, The University of Texas Health Science Center, Houston
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
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)?
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