Clinical trial NCT03953612: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Official title: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly assigned to 2 doses of PREG (300/500 mg/day) vs placebo (PLA) treatment (N=20/group) over 8 weeks.
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Craving Change in Stress and Cue Relative to Neutral
timeFrame: Experiment during treatment week 2
Secondary outcomes:
measure: Anxiety Change in Stress and Cue Relative to Neutral
timeFrame: Experiment during treatment week 2
measure: Cortisol Level Change in Stress and Cue Relative to Neutral
timeFrame: Experiment during treatment week 2
measure: Pregnenolone Concentration
timeFrame: between weeks 2-3 of treatment
Other outcomes:
measure: Cocaine Dollar Amount During Trial Period
timeFrame: up to 8 weeks
measure: Mean Percent Cocaine Days
timeFrame: up to 8 weeks
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Verica Milivojevic, PhD
role: PRINCIPAL_INVESTIGATOR
References: