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Progesterone Treatment for Cocaine-dependent Women: A Pilot Study (PROG)

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ClinicalTrials.gov Identifier: NCT00632099
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Drug: Oral micronized progesterone
Drug: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Matched Placebo Oral Micronized Progesterone
Hide Arm/Group Description

matched placebo

Placebo: matched placebo

Oral micronized progesterone (up to 400 mg/day)

Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil

Period Title: Overall Study
Started 10 11
Completed 7 8
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             3             3
Arm/Group Title Matched Placebo Oral Micronized Progesterone Total
Hide Arm/Group Description

matched placebo

Placebo: matched placebo

Oral micronized progesterone (up to 400 mg/day)

Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil

Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
41  (9) 45  (8) 43  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
10
 100.0%
11
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
White, non-Hispanic 5 4 9
Black 4 5 9
Hispanic 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10 11 21
1.Primary Outcome
Title Cocaine Abstinence Based on Urine Toxicology Results
Hide Description Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)
Time Frame during last 3 weeks of the trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matched Placebo Oral Micronized Progesterone
Hide Arm/Group Description:

matched placebo

Placebo: matched placebo

Oral micronized progesterone (up to 400 mg/day)

Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil

Overall Number of Participants Analyzed 10 11
Measure Type: Number
Unit of Measure: participants
1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Matched Placebo, Oral Micronized Progesterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 10 weeks of study participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Matched Placebo Oral Micronized Progesterone
Hide Arm/Group Description

matched placebo

Placebo: matched placebo

Oral micronized progesterone (up to 400 mg/day)

Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil

All-Cause Mortality
Matched Placebo Oral Micronized Progesterone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Matched Placebo Oral Micronized Progesterone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/11 (9.09%)    
Eye disorders     
Uveitis  [1]  0/10 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Patient experienced pain and floater and was diagnosed with uveitis. The patient was followed by her ophthalmologist and two weeks later and had outpatient laser surgery for retinal detachment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Matched Placebo Oral Micronized Progesterone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      9/11 (81.82%)    
Eye disorders     
eye discomfort   0/10 (0.00%)  0 2/11 (18.18%)  2
Gastrointestinal disorders     
nausea   1/10 (10.00%)  1 0/11 (0.00%)  0
diarrhea   1/10 (10.00%)  1 0/11 (0.00%)  0
constipation   0/10 (0.00%)  0 1/11 (9.09%)  1
increased appetite   2/10 (20.00%)  2 0/11 (0.00%)  0
General disorders     
headache   6/10 (60.00%)  6 4/11 (36.36%)  4
fatigue   5/10 (50.00%)  5 3/11 (27.27%)  3
dizziness   2/10 (20.00%)  2 0/11 (0.00%)  0
swollen hands   1/10 (10.00%)  1 0/11 (0.00%)  0
increased libido   0/10 (0.00%)  0 1/11 (9.09%)  1
hot flashes   0/10 (0.00%)  0 1/11 (9.09%)  1
dry mouth   0/10 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
chest pain   0/10 (0.00%)  0 1/11 (9.09%)  1
back pain   0/10 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders     
depression   2/10 (20.00%)  2 1/11 (9.09%)  1
anxiety   1/10 (10.00%)  1 1/11 (9.09%)  1
irritability   1/10 (10.00%)  1 1/11 (9.09%)  1
Reproductive system and breast disorders     
abdominal pain/cramps   1/10 (10.00%)  1 3/11 (27.27%)  3
breast tenderness   4/10 (40.00%)  4 2/11 (18.18%)  2
Indicates events were collected by systematic assessment
Given the limited sample size, it was not possible to adequately determine whether OM-PROG may be an effective treatment for cocaine-dependence in women, but it was well tolerated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Suzette Evans
Organization: New York State Psychiatric Institute
Phone: 646-774-6136
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00632099     History of Changes
Other Study ID Numbers: #5568
R01DA022218 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Submitted: March 6, 2008
First Posted: March 10, 2008
Results First Submitted: April 9, 2014
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014