Trial · NCT03953612

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

NCT03953612, Early phase 1, Completed, Yale University; results first posted 2024-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders. Trials, record NCT03953612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03953612

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
NCT number: NCT03953612
Status: Completed
Phases: Early phase 1
Enrollment: 58 participants, actual
Lead sponsor: Yale University
Conditions: Cocaine-Related Disorders
Interventions: Pregnenolone (PREG), Placebos
First posted: 2019-05-16
Last updated: 2024-07-03
Results first posted: 2024-07-03

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Craving Change in Stress and Cue Relative to Neutral	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.
Secondary	Anxiety Change in Stress and Cue Relative to Neutral	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.
Secondary	Cortisol Level Change in Stress and Cue Relative to Neutral	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.
Secondary	Pregnenolone Concentration	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.
Other	Cocaine Dollar Amount During Trial Period	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).
Other	Mean Percent Cocaine Days	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Craving Change in Stress and Cue Relative to Neutral	Experiment during treatment week 2	A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation.	score on a scale	MEAN
SECONDARY	Anxiety Change in Stress and Cue Relative to Neutral	Experiment during treatment week 2	A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation	score on a scale	MEAN
SECONDARY	Cortisol Level Change in Stress and Cue Relative to Neutral	Experiment during treatment week 2	A subset of participants from the full study sample completed the experimental component of stress and cocaine cue provocation	mg/dl	MEAN
SECONDARY	Pregnenolone Concentration	between weeks 2-3 of treatment	A subset of participants from the full study sample completed the experimental component of stress and alcohol cue provocation	ng/mL	MEAN
OTHER_PRE_SPECIFIED	Cocaine Dollar Amount During Trial Period	up to 8 weeks	Intent to Treat Sample Included in Analyses n=55	dollars	MEAN
OTHER_PRE_SPECIFIED	Mean Percent Cocaine Days	up to 8 weeks	Intent to Treat Sample Included in Analyses n=55	percent days	MEAN

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Craving Change in Stress and Cue Relative to Neutral	PREG 300 mg/Day	Stress Craving Change	3.035	Standard Deviation 1.34	score on a scale
Craving Change in Stress and Cue Relative to Neutral	PREG 500 mg/Day	Stress Craving Change	-0.486	Standard Deviation 1.153	score on a scale
Craving Change in Stress and Cue Relative to Neutral	Patients Receiving Placebo	Stress Craving Change	3.959	Standard Deviation 1.115	score on a scale
Craving Change in Stress and Cue Relative to Neutral	PREG 300 mg/Day	Cue Craving Change	0.031	Standard Deviation 1.313	score on a scale
Craving Change in Stress and Cue Relative to Neutral	PREG 500 mg/Day	Cue Craving Change	-1.775	Standard Deviation 1.126	score on a scale
Craving Change in Stress and Cue Relative to Neutral	Patients Receiving Placebo	Cue Craving Change	4.835	Standard Deviation 1.118	score on a scale
Anxiety Change in Stress and Cue Relative to Neutral	PREG 300 mg/Day	Stress Anxiety Change	0.757	Standard Deviation 0.309	score on a scale
Anxiety Change in Stress and Cue Relative to Neutral	PREG 500 mg/Day	Stress Anxiety Change	0.118	Standard Deviation 0.269	score on a scale
Anxiety Change in Stress and Cue Relative to Neutral	Patients Receiving Placebo	Stress Anxiety Change	1.334	Standard Deviation 0.263	score on a scale
Anxiety Change in Stress and Cue Relative to Neutral	PREG 300 mg/Day	Cue Anxiety Change	-0.305	Standard Deviation 0.302	score on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PREG 300 mg/Day	21
Overall Study	STARTED	PREG 500 mg/Day	18
Overall Study	STARTED	Patients Receiving Placebo	19
Overall Study	Intent to Treat Sample Included in Analyses	PREG 300 mg/Day	20
Overall Study	Intent to Treat Sample Included in Analyses	PREG 500 mg/Day	17
Overall Study	Intent to Treat Sample Included in Analyses	Patients Receiving Placebo	18
Overall Study	Dropout Weeks 1-3	PREG 300 mg/Day	1
Overall Study	Dropout Weeks 1-3	PREG 500 mg/Day	1
Overall Study	Dropout Weeks 1-3	Patients Receiving Placebo	0
Overall Study	Dropout Weeks 4-12	PREG 300 mg/Day	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	PREG 300 mg/Day	2	20
other	Headache	Nervous system disorders	PREG 500 mg/Day	2	17
other	Headache	Nervous system disorders	Patients Receiving Placebo	3	18
other	Injury/Pain	General disorders	PREG 300 mg/Day	5	20
other	Injury/Pain	General disorders	PREG 500 mg/Day	3	17
other	Injury/Pain	General disorders	Patients Receiving Placebo	2	18
other	Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	PREG 300 mg/Day	1	20
other	Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	PREG 500 mg/Day	1	17
other	Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	Patients Receiving Placebo	1	18
other	Inflammation/Allergy	General disorders	PREG 300 mg/Day	1	20

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PREG 300 mg/Day	0	20
Total, all-cause mortality	PREG 500 mg/Day	0	17
Total, all-cause mortality	Patients Receiving Placebo	0	18
Total, other adverse events	PREG 300 mg/Day	12	20
Total, other adverse events	PREG 500 mg/Day	13	17
Total, other adverse events	Patients Receiving Placebo	11	18
Total, serious adverse events	PREG 300 mg/Day	1	20
Total, serious adverse events	PREG 500 mg/Day	0	17
Total, serious adverse events	Patients Receiving Placebo	0	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K01DA046561	The role of neuroactive steroids in stress, drug craving and drug use in cocaine use disorders	MILIVOJEVIC, VERICA	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2019 to 2023

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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