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Pregnenolone and Marijuana Dependence

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ClinicalTrials.gov Identifier: NCT02439814
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Marijuana Dependence
Interventions Drug: Pregnenolone
Other: Placebo
Enrollment 21
Recruitment Details Subjects were primarily recruited through media advertisements and word of mouth.
Pre-assignment Details  
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication Placebo: Inactive comparator
Period Title: Overall Study
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title Pregnenolone Placebo Total
Hide Arm/Group Description Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication Placebo: Inactive comparator Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
 100.0%
21
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
26.4
(19 to 49)
25.6
(19 to 36)
26
(19 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
3
  27.3%
1
  10.0%
4
  19.0%
Male
8
  72.7%
9
  90.0%
17
  81.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  63.6%
5
  50.0%
12
  57.1%
White
4
  36.4%
5
  50.0%
9
  42.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Subjective Rating of Marijuana Craving on 1-7 Likert Scale
Hide Description Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.
Time Frame 12:40 to 14:45 (post med administration, post Marijuana cue
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description:
Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
Placebo: Inactive comparator
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.64  (1.71) 0.80  (1.79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description Pregnenolone: Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication Placebo: Inactive comparator
All-Cause Mortality
Pregnenolone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregnenolone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregnenolone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. McRae-Clark
Organization: Medical University of South Carolina
Phone: 843-792-5216
EMail: mcraeal@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02439814     History of Changes
Other Study ID Numbers: PRO42135
First Submitted: April 22, 2015
First Posted: May 12, 2015
Results First Submitted: January 31, 2018
Results First Posted: June 18, 2018
Last Update Posted: June 18, 2018