- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03953612
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
April 1, 2024 updated by: Yale University
To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with cocaine use disorder (CUD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This experimental study aims to examine the effects of PREG on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with CUD; and c) sex differences in all of these outcomes.
The study's hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with CUD.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale Stress Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female individuals, ages 18 to 60.
- Subjects must meet current DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use.
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Exclusion Criteria:
- Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
- Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
- Any current use of opiates or past history of opiate use disorder.
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
- Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
- Abstinent from cocaine for more than two weeks prior to admission.
- Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients receiving PREG
Eligible participants will be randomly assigned to 2 doses of PREG (300/500 mg/day) over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
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2 doses of PREG (300/500 mg/day)
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Placebo Comparator: patients receiving placebo
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
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placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Craving reactivity in the laboratory
Time Frame: between weeks 2-3 of treatment
|
Cocaine craving assessed in laboratory experiment with exposure to stress, drug cues and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo.
Cocaine craving will be assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale where a higher score indicates higher craving.
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between weeks 2-3 of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provoked anxiety
Time Frame: between weeks 2-3 of treatment
|
Anxiety assessed in laboratory experiment with exposure to stress, drug cues and neutral control condition in week 2 of PREG (300mg; 500mg) vs. Placebo treatment.
Anxiety will be assessed using a 10-point visual analog scale (VAS) in which 0="not at all" and 10="extremely high".
|
between weeks 2-3 of treatment
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Plasma cortisol levels as a measure of stress response in the laboratory
Time Frame: between weeks 2-3 of treatment
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Plasma will be collected at each laboratory session to assess cortisol response to stress, drug cue and neutral imagery exposure.
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between weeks 2-3 of treatment
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Pregnenolone levels
Time Frame: between weeks 2-3 of treatment
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To examine the blood plasma levels of pregnenolone in two doses of PREG (300mg; 500mg; bid), and matching placebo (PLA), assessed over a 24 hour period.
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between weeks 2-3 of treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine amount during trial assessed using Timeline Followback Substance Use Calendar and corroborated by self-report on daily smartphone monitoring.
Time Frame: up to 8 weeks
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Daily reporting of amount of cocaine per use day will be assessed by self report on the Timeline Followback Substance Use Calendar and daily reporting on smartphone.
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up to 8 weeks
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Percent cocaine days
Time Frame: up to 8 weeks
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The mean percent cocaine days as assessed by self report on daily smartphone monitoring and corroborated by the Timeline Followback Substance Use Calendar over the 8 week period.
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up to 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Verica Milivojevic, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2019
Primary Completion (Actual)
May 8, 2023
Study Completion (Actual)
May 8, 2023
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
May 14, 2019
First Posted (Actual)
May 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1603017466
- 1K01DA046561-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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