Adults 18 to 60, any sex, with Cocaine-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Craving Change in Stress and Cue Relative to NeutralPrimary· Experiment during treatment week 2
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.
Stress Craving Change
Group
Value
95% CI
PREG 300 mg/Day
3.035
± 1.34
PREG 500 mg/Day
-0.486
± 1.153
Patients Receiving Placebo
3.959
± 1.115
Cue Craving Change
Group
Value
95% CI
PREG 300 mg/Day
0.031
± 1.313
PREG 500 mg/Day
-1.775
± 1.126
Patients Receiving Placebo
4.835
± 1.118
Anxiety Change in Stress and Cue Relative to NeutralSecondary· Experiment during treatment week 2
Anxiety assessed in laboratory experiment with exposure to stress, cocaine cue and neutral control condition in participants receiving PREG (300mg; 500mg) vs. Placebo treatment. Anxiety was assessed using a 10-point visual analog scale (VAS) in which 0="not at all" and 10="extremely high", with the mean score ranging from 0 to 10, and where higher score means higher anxiety. Data presented here is anxiety change in stress relative to neutral and anxiety change in cue relative to neutral, where the possible range in mean change score is -10 to +10.
Stress Anxiety Change
Group
Value
95% CI
PREG 300 mg/Day
0.757
± 0.309
PREG 500 mg/Day
0.118
± 0.269
Patients Receiving Placebo
1.334
± 0.263
Cue Anxiety Change
Group
Value
95% CI
PREG 300 mg/Day
-0.305
± 0.302
PREG 500 mg/Day
0.199
± 0.261
Patients Receiving Placebo
0.959
± 0.265
Cortisol Level Change in Stress and Cue Relative to NeutralSecondary· Experiment during treatment week 2
Plasma was collected at each laboratory session to measure cortisol level and assess change in cortisol response to stress and cocaine cue relative neutral imagery condition exposure. Data presented here are change in cortisol level (mg/dl) in stress relative to neutral condition and cue relative to neutral condition.
Stress Cortisol Level Change
Group
Value
95% CI
PREG 300 mg/Day
-0.3
± 0.55
PREG 500 mg/Day
-0.52
± 0.64
Patients Receiving Placebo
0.71
± 0.9
Cue Cortisol Level Change
Group
Value
95% CI
PREG 300 mg/Day
0
± 0.45
PREG 500 mg/Day
-0.07
± 0.73
Patients Receiving Placebo
0.58
± 0.67
Pregnenolone ConcentrationSecondary· between weeks 2-3 of treatment
Blood plasma concentration of pregnenolone in two doses of PREG (300mg; 500mg), and matching placebo, assessed over a 24 hour period.
Group
Value
95% CI
PREG 300 mg/Day
1.09
± 0.194
PREG 500 mg/Day
1.54
± 0.147
Patients Receiving Placebo
0.5
± 0.146
Cocaine Dollar Amount During Trial PeriodSecondary· up to 8 weeks
Mean dollar amount of cocaine per use day was assessed by daily self report on the Timeline Followback Substance Use Calendar and corroborated by daily self-reporting on smartphone (measurement unit in dollars).
Group
Value
95% CI
PREG 300 mg/Day
12.3
± 17.57
PREG 500 mg/Day
26.44
± 20.59
Patients Receiving Placebo
28.28
± 43.99
Mean Percent Cocaine DaysSecondary· up to 8 weeks
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.
Group
Value
95% CI
PREG 300 mg/Day
19.9
± 20.46
PREG 500 mg/Day
35.12
± 20.05
Patients Receiving Placebo
28.61
± 26.19
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 8 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03953612.