Trial · Interventional

CompletedPhase 2Results postedRegistry data

Neural Substrates of Emotion: Impact of Cocaine Dependence

NCTNCT02682784Other idPRO39699

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 138 participants (actual)
Sponsor: Medical University of South Carolina · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Jul 2015
Primary completion: 27 Jul 2020
Completion: 27 Jul 2020
First posted: 15 Feb 2016 (estimated)
Last update posted: 21 Oct 2021
Conditions: Cocaine Use Disorder

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018201920202021

Ph 2
Neural Substrates of Emotion: Impact of Cocaine Dependence
NCT02682784
Jul 2015 to 27 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Over one million individuals in the United States meet criteria for cocaine use disorders. Relapse rates are highest among cocaine-dependent (CD) populations. Social stress is a significant risk factor for relapse. Data from human neuroimaging studies suggest that "top-down" prefrontal cortical inhibition of amygdala activity controls emotional responses to social stimuli. A growing literature suggests that hypoactivity in the medial prefrontal cortex coupled with increases in amygdala activity underscore the vulnerability of CD individuals to relapse. Neuroimaging studies of corticolimbic network activity (functional connectivity) have been conducted in CD subjects at rest. Compared with healthy controls, CD subjects exhibited lower corticolimbic connectivity and the degree of corticolimbic uncoupling was associated with time to relapse. Studies measuring corticolimbic connectivity during exposure to a social stress task in CD subjects could provide critical insight into the neurobiologic mechanisms that underscore the sensitivity of CD individuals to social stress. Moreover interventions that improve corticolimbic connectivity in CD subjects may be effective therapeutic strategies for preventing relapse in CD populations. Oxytocin (OT) is an anxiolytic neuropeptide that attenuates amygdala responses to aversive social cues. In order to better understand the neurobiologic mechanisms that control emotion-related behavior in CD populations, we propose a double-blind placebo (PBO) controlled study using blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) to measure (1) corticolimbic functional connectivity during the Montreal Imaging Stress Task (MIST) and (2) amygdala activity in response to an implicit facial affect recognition paradigm in groups of CD individuals (CD n=80) and healthy non-dependent controls (HC, n=80). Prior to the scanning session, participants will receive either intranasal OT (24 IU) or PBO spray (n=40 per treatment group). The order of the tasks will be counterbalanced.

Interventions

OxytocinDrug
PlaceboDrug

Arms4

Experimental
Oxytocin/Cocaine User
Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.
Active comparator
Placebo/Cocaine User
Individuals who meet criteria for cocaine use disorder and are randomized to placebo.
Experimental
Oxytocin/Control
Healthy controls who are randomized to oxytocin.
Active comparator
Placebo/Control
Healthy controls who are randomized to placebo.

Primary outcomes2

Outcomes the sponsor listed as primary.

Functional Connectivity Between Corticolimbic Brain Regions During Acute Social Stress
Time frame · During Montreal Imaging Stress Task in fMRI scanner
Registry description
Psychophysiological interaction (PPI) analysis measures how strongly one region of the brain is connected to another brain region during a particular experimental condition, such as doing arithmetic while being given feedback about performance. The strength of this functional connection between two regions can be expressed as a parameter estimate - the higher the value of the parameter estimate, the more strongly connected the two regions are so that as activation in one region increases, activation in the connected region also increases. However, two regions can also be strongly negatively connected such that if activation in one region goes up during a task condition, activation in the other region goes down
Amygdala Activity in Response to Fearful Faces
Time frame · During Facial Recognition Task in fMRI scanner
Registry description
Use an implicit facial affect recognition paradigm to determine the impact of cocaine dependence and oxytocin on amygdala activity in response to fearful faces. The BOLD signal measured during neutral faces will be subtracted from the BOLD signal measured during fearful faces.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· During Montreal Imaging Stress Task in fMRI scanner

Functional Connectivity Between Corticolimbic Brain Regions During Acute Social Stress

Group	Value (Arbitrary units)	Spread
Oxytocin/Cocaine User	.011	.099
Placebo/Cocaine User	.012	.103
Oxytocin/Control	.043	.097
Placebo/Control	.0008	.149

Primary outcomeMean· During Facial Recognition Task in fMRI scanner

Amygdala Activity in Response to Fearful Faces

Group	Value (Bold signal)	Spread
Oxytocin/Cocaine User	8.33	48.9
Placebo/Cocaine User	2.32	47.6
Oxytocin/Control	11.98	30.4
Placebo/Control	18.07	30.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin/Cocaine UserIndividuals who meet criteria for cocaine use disorder and are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	0 / 39	0 / 39	0 / 39
Placebo/Cocaine UserIndividuals who meet criteria for cocaine use disorder and are randomized to placebo. Placebo	0 / 35	0 / 35	0 / 35
Oxytocin/ControlHealthy controls who are randomized to oxytocin. Oxytocin: Nasal spray based on naturally occurring hormone, oxytocin.	0 / 27	0 / 27	0 / 27
Placebo/ControlHealthy controls who are randomized to placebo. Placebo	0 / 29	0 / 29	0 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

General Inclusion/Exclusion Criteria Inclusion Criteria 1. Age 18-65. 2. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for the three-day period immediately prior to the study visit. 4. Subjects must consent to random assignment. 5. Subjects must have a negative breathalyzer, urine drug screen at the study visit. 6. Subjects must consent to the study visit which includes an outpatient visit to the ASD and completing one functional magnetic resonance imaging (fMRI) scanning session. Exclusion Criteria 1. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes. 2. Subjects with a history of or current psychotic disorder or bipolar affective disorder. 3. Subjects with current major depressive disorder or post-traumatic stress disorder. 4. Subjects taking any psychotropic medications, including SSRI's or other antidepressants, opiates or opiate antagonists. Subjects taking trazodone or non-benzodiazepene hypnotics for sleep will be included. 5. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. 6. Subjects who have a BMI that procludes them from fitting comfortably in the scanner. 7. Persons with ferrous metal implants or pacemaker. 8. Subjects that are claustrophobic. 9. Subjects with significant psychiatric or medical problems that would impair participation or limit ability to complete the scanning session. 10. Subjects that require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI data acquisition. Group - Specific Inclusion/Exclusion Criteria Individuals with Cocaine Dependence Inclusion Criteria 1\. Subjects must meet DSM-5 criteria for current (three months prior to study visit) moderate to severe cocaine use disorder. Individuals may meet criteria for mild marijuana use disorder, but they must not meet criteria for substance use disorder for any other substance (except nicotine) within the 60 days prior to study participation. Due to the high comorbidity of alcohol and cocaine use disorder individuals with alcohol use disorder will be included in the study if they do not require medically supervised detoxification. Exclusion Criteria 1. Subjects meeting DSM-5 criteria for substance use disorder (other than nicotine, cocaine, marijuana or alcohol) within the 60 days prior to study participation. Healthy Controls Inclusion Criteria 1\. As above. Exclusion Criteria 1. Subjects meeting DSM-5 criteria for current or lifetime substance use disorder on any drugs of abuse (except nicotine and marijuana. 2. Subjects meeting DSM-5 criteria for marijuana use disorder within the last year. 3. Subjects with current major depression or post-traumatic stress disorder (past month)

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