The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

Cocaine-Related Disorders Clinical Trial

Official title:

The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953612
• Other study ID #: 1603017466
• Secondary ID: 1K01DA046561-01A
• Status: Completed
• Phase: Early Phase 1
• Start date: March 12, 2019
• Est. completion date: May 8, 2023

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• PREG 300/500 mg
2 doses of PREG (300/500 mg/day)
• Placebos
placebo

Locations

Country	Name	City	State
United States	Yale Stress Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cocaine amount during trial assessed using Timeline Followback Substance Use Calendar and corroborated by self-report on daily smartphone monitoring.	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.	up to 8 weeks
Other	Percent cocaine days	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.	up to 8 weeks
Primary	Craving reactivity in the laboratory	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.	between weeks 2-3 of treatment
Secondary	Provoked anxiety	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
Secondary	Plasma cortisol levels as a measure of stress response in the laboratory	Plasma will be collected at each laboratory session to assess cortisol response to stress, drug cue and neutral imagery exposure.	between weeks 2-3 of treatment
Secondary	Pregnenolone levels	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.	between weeks 2-3 of treatment