Early Phase 1
N=58
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Cocaine-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03953612 ↗Enrolled (actual)
58
Serious AEs
1.8%
Results posted
Jul 2024
Primary outcome: Primary: Craving Change in Stress and Cue Relative to Neutral — 3.035; -0.486; 3.959; 0.031 score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Pregnenolone (PREG) (Drug); Placebos (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Craving Change in Stress and Cue Relative to Neutral |
3.035; -0.486; 3.959; 0.031; -1.775; 4.835 | <.001 sig |
| SECONDARY Anxiety Change in Stress and Cue Relative to Neutral |
0.757; 0.118; 1.334; -0.305; 0.199; 0.959 | <.001 sig |
| SECONDARY Cortisol Level Change in Stress and Cue Relative to Neutral |
-0.3; -0.52; 0.71; 0; -0.07; 0.58 | 0.7 |
| SECONDARY Pregnenolone Concentration |
1.09; 1.54; 0.5 | 0.0001 sig |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03953612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.