NCT04181515|WithdrawnPhase 2DMCFDA Drug
Study Stopped
Lack of funding
Loading search results
Lack of funding
OTC-1
Using Repetitive Transcranial Magnetic Stimulation (rTMS) to Explore Neural Mechanisms of Stress-Induced Opioid Use
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
April 10, 2023
Actual (reported)Primary Completion
April 10, 2023
Actual (reported)Study Completion
April 10, 2023
Actual (reported)This study will use a stress (vs. placebo) exposure model, paired with single-session sham vs. active rTMS at two distinct cortical locations (dlPFC vs. mPFC in parallel groups) to assess whether rTMS neuromodulation at these alternative loci differentially influence stress-reactivity and opioid reinforcement in non-treatment seeking participants with OUD. Stress-reactivity will be measured using cognitive, affective, behavioral and biological phenotypes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2019
Actual (reported)November 29, 2019
Actual (reported)April 10, 2023
Actual (reported)April 10, 2023
Actual (reported)April 10, 2023
Actual (reported)Addiction Stroop task
reaction time (msec) measure of cognitive interference
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Digit Span Task
number of digits recalled, measure of verbal working memory
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Wisconsin Card Sorting Task
number of correct items, measures ability to shift set and assesses cognitive flexibility
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Monetary Incentive Delay task
number of rewards received, measure of motivation
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Delay Discounting task
rate of monetary discounting
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
placebo stressor (lactose), sham rTMS (inactive coil)
placebo stressor (lactose), active rTMS (10 Hz dlPFC in group 1; 1 Hz mPFC in group 2)
placebo stressor
Yohimbine 54mg + Hydrocortisone 20mg
Mark Greenwald, PhD
Wayne State University
0 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2019
First Posted
November 29, 2019
Cannabidiol in the Treatment of Opioid Use Disorder
Drug/Money Choice Task
number of hypothetical choices between a constant amount of preferred opioid (relative to money)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Blood pressure
Systolic/diastolic BP (mm Hg)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Heart rate
Heart rate (beats/min)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Saliva cortisol level
Saliva cortisol level (µg/dL)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Saliva alpha-amylase level
Saliva alpha-amylase level (U/mL)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Serum prolactin level
Serum prolactin level (pg/dL)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Serum BDNF level
Serum brain derived neurotrophic factor level (pg/dL)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Positive and Negative Affect Schedule (PANAS) positive affect
10-item sub scale score of positive affect
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Positive and Negative Affect Schedule (PANAS) negative affect
10-item sub scale score of negative affect
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
State Trait Anxiety Inventory
state anxiety scores
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Desire for Drug Questionnaire
opioid craving score
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Opiate-32 Questionnaire, Agonist score
total opioid agonist score (16 items)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Opiate-32 Questionnaire, Withdrawal score
total opioid withdrawal symptom score (16 items)
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
Resting-state EEG activation
relative (gamma band ÷ slow band) ratio in electroencephalogram (EEG) power during resting state
change from pre- and post-intervention in each of 4 sessions (through study completion, about 1 month total)
stressor (yohimbine 54mg + hydrocortisone 20mg), sham rTMS (inactive coil)
stressor (yohimbine 54mg + hydrocortisone 20mg), active rTMS (10 Hz dlPFC in group 1; 1 Hz mPFC in group 2)
sham rTMS (inactive coil)
active rTMS (10 Hz dlPFC stimulation in group 1; 1 Hz mPFC stimulation in group 2)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
April 10, 2023
Actual (reported)Primary Completion
April 10, 2023
Actual (reported)Study Completion
April 10, 2023
Actual (reported)Last Updated
April 13, 2023
Record last verified: 2023-04
After the study is completed, qualified investigators may apply in writing to receive the study protocol. At this time, it has not been determined whether data will be shared and the conditions for access.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: