Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder
ConditionOpioid Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-60
SponsorWayne State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet DSM-5 criteria for OUD;
Age 21-60 yr;
Right handed;
Males and non-pregnant/non-lactating females;
Disqualifiers
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);
Trial design
Design model
Crossover
Treatments tested in this trial
Yohimbine + Hydrocortisone
DrugYohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)
Active rTMS
Device10Hz rTMS over the left dlPFC
Placebo
Druglactose (inside capsule)
Sham rTMS
Deviceinactive stimulation over the left dlPFC
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: placebo stressor, sham rTMSPlacebo comparator 2 interventions
Group B: placebo stressor, active rTMSExperimental treatment 2 interventions
Group C: active stressor, sham rTMSExperimental treatment 2 interventions
Group D: active stressor, active rTMSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Color-Word Stroop Task
measures cognitive control in response to opioid-related words.
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)2
Digit Span Task
measures verbal working memory. Participants are asked to repeat strings of numbers of increasing length, both forward and backward.
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)3
Wisconsin Card Sorting Task
measures ability to shift set and assesses cognitive flexibility.
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)4
Emotion Regulation Task
subjects rate the unpleasantness and arousal of different emotional pictures
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)Secondary outcomes
1
Opioid craving
Desire for Drug Questionnaire total score; higher scores indicate greater craving
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)2
Opioid agonist symptoms
Opiate-32 questionnaire agonist symptom total score; higher scores indicate greater opioid symptom severity
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)3
Opioid withdrawal symptoms
Opiate-32 questionnaire withdrawal symptom total score; higher scores indicate greater withdrawal severity
Time frame
change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: