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History of Changes for Study: NCT04426214
Neuromodulation and Cognitive Training for Stimulant Use Disorder
Latest version (submitted July 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 9, 2020 None (earliest Version on record)
2 September 2, 2020 Sponsor/Collaborators, Study Status, Oversight and Study Identification
3 May 11, 2021 Study Status, Contacts/Locations and Study Design
4 July 16, 2021 Recruitment Status, Contacts/Locations, Study Status, Eligibility, Study Description, Study Identification, Document Section, Study Design and Conditions
5 July 15, 2022 Study Status
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Study NCT04426214
Submitted Date:  June 9, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: STUDY00009059
Brief Title: Neuromodulation and Cognitive Training for Stimulant Use Disorder
Official Title: Neuromodulation and Cognitive Training for Stimulant Use Disorder
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020
Overall Status: Not yet recruiting
Study Start: September 2020
Primary Completion: March 2022 [Anticipated]
Study Completion: June 2022 [Anticipated]
First Submitted: May 29, 2020
First Submitted that
Met QC Criteria:
June 9, 2020
First Posted: June 11, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 9, 2020
Last Update Posted: June 11, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Minnesota
Responsible Party: Principal Investigator
Investigator: Kelvin Lim
Official Title: Professor
Affiliation: University of Minnesota
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The relapsing nature of Stimulant use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. The study testing a new intervention, namely tDCS-Augmented Cognitive Training to engage these brain biomarkers to improve cognition and improve treatment outcomes.
Detailed Description:

The relapsing nature of Stimulant use disorder is a major obstacle to successful treatment. About 70% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem.

2.2 Preliminary Data: Using resting functional magnetic resonance imaging (fMRI) the team has identified brain biomarkers that support long-term abstinence. Our cross-sectional and longitudinal findings provide evidence that higher FC, particularly between NAcc and DLPFC, is a potential brain biomarker that supports abstinence. Long-term abstinent alcoholics (7 years of abstinence) have higher resting FC between NAcc and DLPFC when compared to controls. Short-term abstinent alcoholics (11 weeks of abstinence) have intermediate FC (lower than long-term abstinent alcoholics and higher than controls). Further, lower FC between NAcc and DLPFC at 11 weeks of abstinence can be a predictor of subsequent relapse (with 74% accuracy). Moreover, in a pilot longitudinal FC study examining resting FC of NAcc at 5 and 13 weeks of abstinence in individuals with substance use disorder, we found that FC between NAcc and DLPFC decreased from 5 to 13 weeks of abstinence in subsequent relapsers, while it increased in subsequent abstainers. Based on the above, the investigators believe that long-term abstinence is supported by a compensatory mechanism that mediates proper executive function over reward (mediated by DLPFC-NAcc FC), a potential brain biomarker that could be an intervention target. These findings provide a compelling case to explore whether this brain biomarker can be modulated to enhance patients' ability to remain abstinent. There is a need to investigate methods that can be used to increase FC between DLPFC and NAcc.

2.3 Existing Literature: Executive functioning, the ability to change maladaptive behavior, depends on DLPFC input to NAcc. DLPFC transmits reward representations to NAcc through glutamatergic projections that guide goal-directed behavior. If DLPFC fails to activate when required, a common observation in substance use disorder, target neurons in the NAcc core do not receive critical information needed to select the appropriate outcome, causing acquired maladaptive response patterns to persist (e.g. drug consumption). Higher FC between DLPFC and NAcc may be achieved by stimulating DLPFC while subjects perform engaging executive functioning tasks. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity. DLPFC stimulation may increase input to NAcc to facilitate proper selection of goal-directed behavior and may also decrease craving in individuals with substance use disorder. Genetics and treatment response: A source of treatment response variability could stem from differences between participants in baseline genetic profiles or epigenetic changes over the course of treatment. Genetic polymorphisms, especially in genes important for neuroplasticity, may also mediate neuroplastic changes underlying the effects of tDCS, as has been demonstrated with gene BDNF. In light of these genetic influences on key tenants of our study - i.e. treatment response in alcohol use disorder and physiological effects of tDCS - genetic samples from participants will be collected to determine whether genetic or epigenetic variations may affect response to the cognitive training and tDCS intervention. This information may help inform the development of more individually-tailored treatment protocols in the future. As this is a secondary aim, participants will be given the choice in the Consent Form to opt in or out of the genetic sampling procedure.

3.0 Study Endpoints/Events/Outcomes 3.1 Primary Endpoint/Event/Outcome: In a double-blind randomized design, 40 abstinent (1-2 weeks abstinent) individuals with Stimulant use disorder (SUD) recruited from Lodging Plus Program will receive 5 sessions (for 5 days) of either (i) transcranial direct current stimulation (tDCS) to PFC or (ii) sham-tDCS. All subjects will perform executive functioning tasks during each tDCS intervention (active or sham) to prime the engagement of the NAcc-PFC brain circuit. Follow-up interviews will be conducted approximately 1 and 2 months after intervention completion (exact timepoint depending on participant availability) to query relapse status. Dependent variables will be (i) change in cognitive performance between pre- and post-intervention, and (ii) relapse status ~2 months after study participation. The Specific Aims are to determine if the intervention: (A1) is feasible and safe in individuals with SUD, (A2) induces cognitive performance changes, and (A3) is related to relapse status ~2 months after study. A fourth exploratory aim is to examine relationships between genetic variants, epigenetic changes and (A2-3).

To evaluate feasibility (A1), withdrawal and retention policies are described in Section 12.0. To evaluate safety (A1), = the Treatment Side Effects Questionnaire will be used to record intervention side effects. Based on our alcohol tDCS study and studies from other research groups, it is hypothesized that the intervention will be feasible and safe.

To evaluate cognitive performance changes (A2), comparisons will be made on cognitive performance change from pre-intervention to post-intervention) between active tDCS and sham groups. It is hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group.

To evaluate relapse status at follow-up (approximately 1- and 2-months later; A3), the investigators will conduct Timeline Follow Back, questionnaire and saliva/urine samples at each follow-up. Based on our alcohol pilot study and literature on the effects of tDCS in other addictions, it is hypothesized that the active tDCS group will have lower relapse rates and longer abstinence periods than the sham group.

3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): To determine generalization and durability of cognitive training, patients will be asked to complete the following tasks at pre-intervention, post-intervention, 1-month follow-up, and 2-month follow-up to examine generalization and durability effects of training: D-KEFS Trail Making Test, D-KEFS Verbal Fluency, D-KEFS Color Word, Rey 15-item Visual Memory test, Rey Auditory Verbal Learning Test, Digit-Span (WAIS-WISC), Digit Symbol (WAIS-WISC).

Open or close this module Conditions
Conditions: Stimulant Use
Keywords: tDCS
Cognitive Training
Plasticity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active tDCS Device: tDCS
We will apply tDCS in combination with cognitive training. All participants receive cognitive training, and will be randomized to receive either active or sham tDCS
Behavioral: Cognitive Training
cognitive training on computer
Placebo Comparator: Sham tDCS Behavioral: Cognitive Training
cognitive training on computer
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percent of participants with clean drug screens
[ Time Frame: 2 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Abstinent individuals (18-65 years old; 1-2 weeks abstinent) who meet DSM-IV criteria for Stimulant use disorder (SUD)
  • ability to provide written consent and comply with study procedures;

Exclusion Criteria:

  • Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
  • a head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
  • presence of a condition that would render study measures difficult or impossible to administer or interpret
  • age outside the range of 18 to 65
  • primary current substance use disorder diagnosis on a substance other than Stimulant except for caffeine or nicotine
  • left handedness
  • entrance to the treatment program under a court mandate
Open or close this module Contacts/Locations
Central Contact Person: Kathleen Thaemlitz
Telephone: 612-624-6581
Email: kthaemli@umn.edu
Central Contact Backup: Elias Boroda
Telephone: 7634984176
Email: borod002@umn.edu
Locations: United States, Minnesota
University of Minnesota Fairview
Minneapolis, Minnesota, United States, 55454
Contact:Contact: Elias Boroda 763-498-4176 borod002@umn.edu
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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