Test d'un protocole TMS accéléré pour les troubles liés à l'usage de méthamphétamine
The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Anschutz Medical Campus
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 21-65 years inclusive;
- Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- Provides a urine drug screen positive for methamphetamine;
- Able to provide informed consent;
- No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
- Adequate English proficiency for study consent, and completion of the study instruments.
Exclusion Criteria:
- Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
- Presence of a clinically significant abnormality on baseline MRI;
- Inability to have an MRI;
- Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
- Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
- History of head injury with loss of consciousness for more than 15 minutes;
- Diagnosis of dementia;
- Prescribed benzodiazepines or anticonvulsants;
- Currently enrolled in formal substance use disorder treatment;
- Metal implants or non-removable metal objects above the waist;
- Lifetime history of prior clinical treatment with TMS;
- Serious risk of suicide or homicide;
- Unable/unwilling to follow the study procedures;
- History of intractable migraine;
- Assessed to be at risk for alcohol or opioid withdrawal.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Sham TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure. |
|
Expérimental: Active TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tolerability
Délai: 5 days
|
Proportion completing at least 20 TMS session - sham vs. active |
5 days
|
|
Study emergent adverse events
Délai: 12 weeks
|
Incidence of study emergent adverse events - sham vs. active |
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Weeks of continuous abstinence
Délai: 12 weeks
|
Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen. |
12 weeks
|
|
Days of methamphetamine use
Délai: 12 weeks
|
Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview. |
12 weeks
|
|
Time to first methamphetamine use
Délai: 12 weeks
|
Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen |
12 weeks
|
|
Methamphetamine craving
Délai: 12 weeks
|
Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving. |
12 weeks
|
|
Methamphetamine craving on visual analog scale
Délai: 12 weeks
|
Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving. |
12 weeks
|
|
MRI cue craving
Délai: Pre- and Post- TMS stimulation in week 1
|
Cue craving data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
|
MRI resting state
Délai: Pre- and Post- TMS stimulation in week 1
|
Resting state data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 23-1044
- K24DA058882 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No plan to share IPD.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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