Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

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• Opioid-Related Disorders 1,410
• Heroin Dependence 87

Study arms

• Experimental
  tDCS with Cognitive Training

  DLPFC stimulation with tDCS with simultaneous cognitive training

  Device: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Cognitive Training

• Active comparator
  Sham tDCS with Cognitive Training

  Sham tDCS with simultaneous cognitive training

  Device: Sham Transcranial Direct Current Stimulation (tDCS) · Behavioral: Cognitive Training

Interventions

• DeviceTranscranial Direct Current Stimulation (tDCS)

  Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)

• DeviceSham Transcranial Direct Current Stimulation (tDCS)

  Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)

• BehavioralCognitive Training

  Executive functioning tasks

Primary outcomes

1. (A1) Average Number of Serious Adverse Events in Active and Sham Groups.

   Safety was defined as the prevalence of Serious Adverse Events for the study. Subjects were monitored for Serious Adverse Events from date of first intervention session until the final follow-up visit (2 months post-intevention). Subjects were monitored using the Symptom Rating Questionnaire (SRQ), Medication/Medical Update Interview, and medical chart review. Serious Adverse Events were defined as: Death, life threatening incidents, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or an event that required intervention to prevent permanent impairment or damage. Mean and standard deviation of Serious Adverse Events was recorded across groups. A lower number indicates fewer Serious Adverse Events.

   Time frame: 2months post-intervention

2. (A2) Activation Levels in Brain Circuits in Active and Sham Groups.

   Brain activation change from pre-intervention to post-intervention was planned to be compard between active tDCS and sham groups. We hypothesized that the active tDCS group will have a larger increase in brain circuit engagement than the sham group and, thus, a better outcome.

   Time frame: 1-week post-intervention

3. (A3) Changes in Scaled Score on Digit Span Task.

   Cognitive performance change was compared between active tDCS and sham groups. Cognitive performance change was defined as improvement on the WAIS-IV Digit Span (DS). Score was calculating by subtracting the DS scaled score at baseline from the DS scaled score at 2-Month Follow Up. We hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group. A higher number indicates a higher impact of cognitive training and, thus, a better outcome. The DS Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two DS Scaled Scores has a range of -9 (min.) to 9 (max.)

   Time frame: 2 months post-intervention

4. (A4) Number of Participants Who Relapsed After Intervention.

   Relapse was defined as any illiciit drug use (whether reported by the patient or reported as a positive drug screen in study or medical records) that occurred at some point between study intervention and the final follow-up visit (2 months post-intervention). Relapse was measured with the Timeline Follow Back questionnaire, saliva drug screen at the study visit, and chart review of urine drug screens. Relapse was coded 0 (did not relapse during the study) or 1 (relapsed during the study). We hypothesized that the active tDCS group will have a lower relapse rate than the sham group. A higher number indicates a higher count of participants with a relapse.

   Time frame: 2 months post-intervention

Secondary outcomes

1. Changes in Scaled Score on Digit Symbol Task.

   "Durability of cognitive training was defined as improvement on the WAIS-IV Digit Scale Symbol/Coding (CD) test. The improvement period was measured between baseline and the study completion (2 months post-intervention). The score was calculated by subtracting the CD scaled score at baseline from the CD Scaled Score at 2-months post-intervention. A higher number indicates a higher impact on cognitive abilities, and a better outcome. The CD Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two CD Scaled Scores has a range of -9 (min.) to 9 (max.)"

   Time frame: 2-months post-intervention

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Feb 11, 2022
• Informed consent form · Mar 8, 2022

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