- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07490600
[Studie přístroje, který není schválen ani očištěn americkým Úřadem pro kontrolu potravin a léčiv (FDA)]
[Studie přístroje, který není schválen nebo certifikován americkým Úřadem pro kontrolu potravin a léčiv (FDA)]
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Joy M Schmitz, PhD
- Telefonní číslo: (713) 486-2867
- E-mail: Joy.M.Schmitz@uth.tmc.edu
Studijní záloha kontaktů
- Jméno: Jessica Vincent
- Telefonní číslo: 713 486 2803
- E-mail: Jessica.N.Vincent@uth.tmc.edu
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77030
- Nábor
- The University of Texas Health Science Center at Houston
-
Kontakt:
- Joy M Schmitz, PhD
- Telefonní číslo: (713) 486-2867
- E-mail: Joy.M.Schmitz@uth.tmc.edu
-
Kontakt:
- Jessica Vincent
- Telefonní číslo: 713 486 2803
- E-mail: Jessica.N.Vincent@uth.tmc.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Falešný srovnávač: 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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Experimentální: CM for 2 weeks, then TMS experimental plus CM
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of participants who test negative for cocaine use as assessed by urine drug screen
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Cue-induced craving as assessed by VAS during cue task
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Joy M Schmitz, PhD, The University of Texas Health Science Center, Houston
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HSC-MS-25-0782
- 1U01DA064181-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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