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Neural Substrates of Emotion: Impact of Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT02682784
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: Oxytocin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Substrates of Emotion: Impact of Cocaine Dependence
Study Start Date : July 2015
Actual Primary Completion Date : July 27, 2020
Actual Study Completion Date : July 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxytocin/Cocaine User
Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.
Drug: Oxytocin
Nasal spray based on naturally occurring hormone, oxytocin.
Other Name: Pitocin

Active Comparator: Placebo/Cocaine User
Individuals who meet criteria for cocaine use disorder and are randomized to placebo.
Drug: Placebo
Experimental: Oxytocin/Control
Healthy controls who are randomized to oxytocin.
Drug: Oxytocin
Nasal spray based on naturally occurring hormone, oxytocin.
Other Name: Pitocin

Active Comparator: Placebo/Control
Healthy controls who are randomized to placebo.
Drug: Placebo



Primary Outcome Measures :
  1. Functional connectivity between corticolimbic brain regions during acute social stress [ Time Frame: During Montreal Imaging Stress Task in fMRI scanner ]
  2. Amygdala activity in response to fearful faces [ Time Frame: During Facial Recognition Task in fMRI scanner ]

Secondary Outcome Measures :
  1. Subjective stress score on 0-10 Likert scale [ Time Frame: 1 minute post fMRI scan ]
  2. Subjective craving score on 0-10 Likert scale [ Time Frame: 1 minute-post fMRI scan ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682784


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Aimee L McRae-Clark, PharmD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02682784    
Other Study ID Numbers: PRO39699
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs