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

NCT03953612 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: 16030174661K01DA046561-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Craving Change in Stress and Cue Relative to Neutral

  Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the possible range in mean change score is -6 to +6.

  Experiment during treatment week 2

Secondary Outcomes (3)

• Anxiety Change in Stress and Cue Relative to Neutral

  Experiment during treatment week 2

• Cortisol Level Change in Stress and Cue Relative to Neutral

  Experiment during treatment week 2

• Pregnenolone Concentration

  between weeks 2-3 of treatment

Other Outcomes (2)

• Cocaine Dollar Amount During Trial Period

  up to 8 weeks

• Mean Percent Cocaine Days

  up to 8 weeks

Study Arms (3)

PREG 300

EXPERIMENTAL

Eligible participants will be randomly assigned to PREG 300 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.

Drug: Pregnenolone (PREG)

patients receiving placebo

PLACEBO COMPARATOR

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.

Drug: Placebos

PREG 500

EXPERIMENTAL

Eligible participants will be randomly assigned to PREG 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.

Drug: Pregnenolone (PREG)

Interventions

Pregnenolone (PREG) DRUG

2 doses of PREG (300 or 500 mg/day)

PREG 300; PREG 500

Placebos DRUG

placebo

patients receiving placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Results Point of Contact

• Title: Verica Milivojevic, PhD
• Organization: Yale School of Medicine

verica.milivojevic@yale.edu

203-737-5201

Study Officials

• Verica Milivojevic, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 16, 2019
• Study Start: March 12, 2019
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Locations

US (1)