Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yohimbine + Hydrocortisone, Active rTMS, Placebo, Sham rTMS.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Pharmacological Stress and Repetitive Transcranial Magnetic Stimulation Interventions on Executive Function in Opioid Use Disorder
Overview
This preliminary study is designed to evaluate mechanisms by which excitatory dorsolateral prefrontal cortex (dlPFC) repetitive transcranial magnetic stimulation (rTMS) (vs. sham) and pharmacological stress (vs. placebo) alter behavior in non-treatment seeking individuals with opioid use disorder (OUD). Specific Aims are to (1) Evaluate how stress impacts domains of behavior including (1a) executive function and (1b) opioid-seeking behavior; and (2) Determine whether rTMS stimulation attenuates (2a) executive dysfunction, (2b) stress-reactivity, and (2c) opioid-seeking in individuals with OUD not receiving treatment.
Detailed description
This study will use a double-blind, 10Hz left dlPFC rTMS (vs. sham) and pharmacological stressor (\[yohimbine + hydrocortisone\] vs. placebo) within-subject, randomized crossover design. Each participant will complete 4 sessions (stressor vs. placebo, crossed with rTMS vs. sham), each separated by at least 1 week. Participants will complete these 4 (2x2 within subject) test conditions in randomized order: sham rTMS/placebo stress, sham rTMS/active stress, active rTMS/ placebo stress, and active rTMS/active stress.
The PI will perform randomization using a Latin Square and will assign participants to conditions and prepare medication (stressor or placebo) for each participant's sessions. The PI will keep others blinded and will not be involved in study assessments.
Interventions
- Drug Yohimbine + Hydrocortisone
Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule) - Device Active rTMS
10Hz rTMS over the left dlPFC - Drug Placebo
lactose (inside capsule) - Device Sham rTMS
inactive stimulation over the left dlPFC
Primary outcome measures
- Color-Word Stroop Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Digit Span Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Wisconsin Card Sorting Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Emotion Regulation Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Positive and Negative Affect Schedule [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- State-Trait Anxiety Inventory [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Monetary Incentive Delay Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Delay Discounting Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Drug/Money Choice Task [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Systolic blood pressure [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
Secondary outcome measures (3)
- Opioid craving [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Opioid agonist symptoms [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
- Opioid withdrawal symptoms [Time frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)]
Eligibility criteria
Inclusion criteria
- Meet DSM-5 criteria for OUD;
- Age 21-60 yr;
- Right handed;
- Males and non-pregnant/non-lactating females;
- cognitively intact (total IQ score >80 on Shipley Institute of Living Scale);
- Screening cardiovascular indices within ranges for safe use of the pharmacological stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg;
- Use alcohol and/or marijuana <3 times/week; each "time" should consist of <1 marijuana "joint" equivalent and <3 alcoholic drinks.
Exclusion criteria
- Under influence of any substance during session;
- Past 7-day use of illicit drugs other than opioids (except marijuana, which is legal in Michigan);
- Urinalysis positive for cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy;
- Medical conditions prohibiting use of rTMS (e.g. seizure history; based on rTMS screening questionnaire);
- Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, or obsessive compulsive disorder; major depression in the past 5 years; or potentially antisocial personality disorder (if the clinical psychologist judges such behaviors to be potentially disruptive or unsafe in our lab);
- Past-year SUD other than OUD;
- Acute/unstable illness: conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases);
- Lactose intolerance (placebo dose);
- Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications;
- Chronic head or neck pain; and
- Past-month participation in a research study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Tolan Park Medical Building — Detroit
Identifiers
NCT: NCT04231708 · DL-STR-OUD