The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.
Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use. Specific aim 2: To obtain information about the safety and tolerability of progesterone treatment in the postpartum period. Hypothesis 2: Side effects for progesterone will be similar to those of placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
100mgs progesterone twice daily
Matched placebo pills to be taken twice daily
Yale School of Medicine
New Haven, Connecticut, United States
Mean Number of Days Per Week of Cocaine Use
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.
Time frame: Weekly measurements, Baseline to 12 weeks
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar
Time frame: baseline, end of trial (week 12), 3-month post-trial follow-up
Proportion of Positive Urine Samples Per Week
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Time frame: weekly measurements, baseline to 12 weeks
Proportion of Positive Urine Samples Per Week
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Time frame: baseline, end of trial (week 12) and 3-month post-trial follow-up
Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.
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Time frame: 12 weeks postpartum
Cocaine Craving (Measured Weekly Using CCQ-Brief)
CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.
Time frame: baseline to 12 weeks
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.
Time frame: baseline to 12 weeks
Salivary Progesterone Concentrations
A comparison of salivary progesterone concentrations across all samples for all timepoints
Time frame: week 2, week 6, week 10, week 12