Trial Outcomes & Findings for PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT) (NCT NCT05128071)
NCT ID: NCT05128071
Last Updated: 2026-06-03
Results Overview
Recruit and enroll 40 eligible women (postpartum individuals with MUD) in a 15 month period from time of study initiation.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
34 participants
Primary outcome timeframe
15 months after study initiation
Results posted on
2026-06-03
Participant Flow
Participant milestones
| Measure |
Progesterone Arm
Randomized to receive progesterone
Progesterone: Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily
|
Placebo Arm
Randomized to receive placebo
Placebo: Randomized to placebo twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Progesterone Arm
Randomized to receive progesterone
Progesterone: Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily
|
Placebo Arm
Randomized to receive placebo
Placebo: Randomized to placebo twice daily
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Dose Reduction (% completers)
|
2
|
0
|
Baseline Characteristics
PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
16 participants were randomized to the placebo arm
|
Progesterone
n=18 Participants
18 participants were randomized to the treatment arm- progesterone
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 5.4 • n=20 Participants
|
30.8 years
STANDARD_DEVIATION 4.1 • n=20 Participants
|
31.9 years
STANDARD_DEVIATION 4.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
0 participants
n=20 Participants
|
1 participants
n=20 Participants
|
1 participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race : Black
|
0 participants
n=20 Participants
|
3 participants
n=20 Participants
|
3 participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race : Native Hawaiin/ PI
|
0 participants
n=20 Participants
|
1 participants
n=20 Participants
|
1 participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
16 participants
n=20 Participants
|
16 participants
n=20 Participants
|
32 participants
n=40 Participants
|
|
Race/Ethnicity, Customized
More than one Race
|
0 participants
n=20 Participants
|
4 participants
n=20 Participants
|
4 participants
n=40 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 15 months after study initiationRecruit and enroll 40 eligible women (postpartum individuals with MUD) in a 15 month period from time of study initiation.
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Off drug/ non-compliant
|
6 Participants
|
1 Participants
|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Completing per protocol
|
8 Participants
|
13 Participants
|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Lost/Withdrawn/ refused
|
2 Participants
|
2 Participants
|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Retained
|
16 Participants
|
14 Participants
|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Completing
|
10 Participants
|
13 Participants
|
|
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Dose Reduction
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksNumber of enolled participants with Severe Medication Side Effects
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Number of Participants With Severe Medication Side Effects
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: The table below indicated the mean decrease in scores on the EPDS scale between study arms
A lower score on the Edinburgh Postpartum Depression Scale (EPDS) scale indicates a better outcome. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item screening tool (maximum score 30) used to identify perinatal depression, where scores 0-9 indicate minimal depression, scores of 10 or higher typically indicate possible depression, and scores of 13 or greater strongly suggest a depressive illness.
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Assess Depression and Suicidality Status in Enrolled Participants
|
1.89 scores on a scale
Interval 1.32 to 2.47
|
2.56 scores on a scale
Interval 1.87 to 3.24
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: The table below indicated the mean decrease in scores on the GAD7 scale between study arms
Assess anxiety status in enrolled participants using validated surveys/ GAD-7 The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-reported questionnaire used to measure anxiety severity over the past two weeks. Scores range from 0 to 21, categorized as mild (0-4), moderate (5-9), moderately severe (10-14), and severe (15-21) anxiety. A score of 10 or higher is the typical cutoff for identifying clinical anxiety
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Assess Anxiety Status in Enrolled Participants
|
1.30 scores on a scale
Interval 0.76 to 1.83
|
2.25 scores on a scale
Interval 1.61 to 2.9
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: The following table indicates the decrease in # of days of tobacco use
Secondarily we assessed the association between the exposures of doses of progesterone administered and tobacco use.
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Difference in Tobacco Use From Baseline
|
-1.20 Days of Tobacco Use
Interval -3.21 to -0.81
|
-3.09 Days of Tobacco Use
Interval -5.69 to -0.49
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksAssess the efficacy of micronized progesterone to decrease return to methamphetamine use (MU) among postpartum women with methamphetamine use disorder. Return to use will be defined as either self-reported MU or positive urine toxicology result. Results will be compared between placebo and active ingredient groups.
Outcome measures
| Measure |
Progesterone
n=18 Participants
Randomized to Progesterone
|
Placebo
n=16 Participants
Placebo Group
|
|---|---|---|
|
Assess Return to Methamphetamine Use (MU) in Enrolled Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Randomized
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized
n=18 participants at risk
Randomized 1:1 to 400 mg oral micronized progesterone daily or placebo
|
Placebo
n=16 participants at risk
Randomized to 400 mg placebo daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Fever and respiratory sx in neonate
|
5.6%
1/18 • Number of events 1 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Gastrointestinal disorders
e. coli uti.
|
5.6%
1/18 • Number of events 1 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Cardiac disorders
pericarditis
|
5.6%
1/18 • Number of events 1 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
rsv bronchiolitis
|
0.00%
0/18 • Baseline through 12 weeks.
|
6.2%
1/16 • Number of events 1 • Baseline through 12 weeks.
|
Other adverse events
| Measure |
Randomized
n=18 participants at risk
Randomized 1:1 to 400 mg oral micronized progesterone daily or placebo
|
Placebo
n=16 participants at risk
Randomized to 400 mg placebo daily
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
9/18 • Number of events 9 • Baseline through 12 weeks.
|
6.2%
1/16 • Number of events 1 • Baseline through 12 weeks.
|
|
Psychiatric disorders
Agitation
|
33.3%
6/18 • Number of events 6 • Baseline through 12 weeks.
|
31.2%
5/16 • Number of events 5 • Baseline through 12 weeks.
|
|
Psychiatric disorders
Anxiety
|
22.2%
4/18 • Number of events 4 • Baseline through 12 weeks.
|
12.5%
2/16 • Number of events 2 • Baseline through 12 weeks.
|
|
Gastrointestinal disorders
Appetite Changes
|
66.7%
12/18 • Number of events 12 • Baseline through 12 weeks.
|
37.5%
6/16 • Number of events 6 • Baseline through 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back or joint pain
|
22.2%
4/18 • Number of events 4 • Baseline through 12 weeks.
|
12.5%
2/16 • Number of events 2 • Baseline through 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Breathing or Lung
|
11.1%
2/18 • Number of events 2 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Psychiatric disorders
Depressed Mood
|
33.3%
6/18 • Number of events 6 • Baseline through 12 weeks.
|
6.2%
1/16 • Number of events 1 • Baseline through 12 weeks.
|
|
General disorders
Dizziness
|
55.6%
10/18 • Number of events 10 • Baseline through 12 weeks.
|
25.0%
4/16 • Number of events 4 • Baseline through 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Mouth
|
44.4%
8/18 • Number of events 8 • Baseline through 12 weeks.
|
18.8%
3/16 • Number of events 3 • Baseline through 12 weeks.
|
|
General disorders
Fatigue
|
55.6%
10/18 • Number of events 10 • Baseline through 12 weeks.
|
12.5%
2/16 • Number of events 2 • Baseline through 12 weeks.
|
|
Gastrointestinal disorders
GI
|
38.9%
7/18 • Number of events 7 • Baseline through 12 weeks.
|
31.2%
5/16 • Number of events 5 • Baseline through 12 weeks.
|
|
General disorders
Hair Loss
|
22.2%
4/18 • Number of events 4 • Baseline through 12 weeks.
|
12.5%
2/16 • Number of events 2 • Baseline through 12 weeks.
|
|
Nervous system disorders
Hand Tingling
|
5.6%
1/18 • Number of events 1 • Baseline through 12 weeks.
|
12.5%
2/16 • Number of events 2 • Baseline through 12 weeks.
|
|
General disorders
Headache
|
77.8%
14/18 • Number of events 14 • Baseline through 12 weeks.
|
50.0%
8/16 • Number of events 8 • Baseline through 12 weeks.
|
|
Gastrointestinal disorders
Nausea/vomitting
|
11.1%
2/18 • Number of events 2 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Reproductive system and breast disorders
Menstruation irr.
|
44.4%
8/18 • Number of events 8 • Baseline through 12 weeks.
|
6.2%
1/16 • Number of events 1 • Baseline through 12 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular
|
38.9%
7/18 • Number of events 7 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
General disorders
Sleep Disruption
|
33.3%
6/18 • Number of events 6 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Cardiac disorders
Tachycardia
|
16.7%
3/18 • Number of events 3 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Renal and urinary disorders
Urinary
|
11.1%
2/18 • Number of events 2 • Baseline through 12 weeks.
|
0.00%
0/16 • Baseline through 12 weeks.
|
|
Blood and lymphatic system disorders
Vasomotor
|
61.1%
11/18 • Number of events 11 • Baseline through 12 weeks.
|
31.2%
5/16 • Number of events 5 • Baseline through 12 weeks.
|
|
General disorders
Other
|
27.8%
5/18 • Number of events 5 • Baseline through 12 weeks.
|
31.2%
5/16 • Number of events 5 • Baseline through 12 weeks.
|
|
General disorders
Infant
|
22.2%
4/18 • Number of events 4 • Baseline through 12 weeks.
|
6.2%
1/16 • Number of events 1 • Baseline through 12 weeks.
|
Additional Information
Elizabeth Turner, Sr. Regulatory Coordinator
University of Utah Health
Phone: 801.201.8929
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place