Cocaine AbuseNCT01249274

Progesterone for Postpartum Cocaine Relapse

A study testing Progesterone in people with Cocaine Abuse and Cocaine Dependence, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Cocaine Abuse, Cocaine Dependence
What is being tested?: Progesterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Jul 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.
Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.
Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.

Who cannot join

Women will be ineligible for the trial if they:
have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;
have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
speak a language other than English;
are planning on moving out of the area in the first six months after delivery;
are unable to understand the study or are unable to provide informed consent;

Show all 12Show fewer

are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);
have pending incarceration;
are currently incarcerated;
are using another progestin;
are unwilling to accept randomization;
are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06510

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Cocaine Abuse, Cocaine Dependence
Being tested: Progesterone, Placebo
Keywords: cocaine abuse, cocaine dependence, postpartum period
Medical subject headings: Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProgesteroneDrug
Also called prometrium
100mgs progesterone twice daily
PlaceboOther
Matched placebo pills to be taken twice daily

Study groups in NCT01249274
Study group	Role	What they receive
Placebo	Placebo comparator	Matched placebo pills to be taken twice daily Receives: Other: Placebo
Progesterone	Experimental	100 mgs progesterone twice daily Receives: Drug: Progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, end of trial (week 12) and 3-month post-trial follow-up

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: baseline to 12 weeks
Salivary Progesterone Concentrations
A comparison of salivary progesterone concentrations across all samples for all timepoints
Measured: week 2, week 6, week 10, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Jul 2013

First posted29 Nov 2010 (estimated)
Study startFeb 2011
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cocaine AbuseStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01249274
Sponsor's protocol ID: 1005006793
Other IDs: R21DA029914
Status last verified: Feb 2017
First submitted: 22 Nov 2010
Last updated: 28 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Data request should be made to the PI

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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RecruitingPhase 4
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All Cocaine Abuse trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Progesterone for Postpartum Cocaine Relapse
ClinicalTrials.gov ID: NCT01249274
Acronym / sponsor ID: 1005006793
Conditions: Cocaine Abuse, Cocaine Dependence
Keywords: cocaine abuse, cocaine dependence, postpartum period
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Feb 2011 (actual)
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 29 Nov 2010 (estimated)
Results: Posted 12 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboMatched placebo pills to be taken twice daily
Progesterone	Experimental	Drug: Progesterone100 mgs progesterone twice daily

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.
Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.
Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.

Key exclusion criteria (12 listed)

have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;
have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
speak a language other than English;
are planning on moving out of the area in the first six months after delivery;
are unable to understand the study or are unable to provide informed consent;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ProgesteroneAlso: prometrium100mgs progesterone twice daily	Drug	Progesterone
PlaceboMatched placebo pills to be taken twice daily	Other	Placebo

Primary outcome

Mean Number of Days Per Week of Cocaine Use
Time frame: Weekly measurements, Baseline to 12 weeks
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.
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
Time frame: baseline, end of trial (week 12), 3-month post-trial 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
Proportion of Positive Urine Samples Per Week
Time frame: weekly measurements, baseline to 12 weeks
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.
Proportion of Positive Urine Samples Per Week
Time frame: baseline, end of trial (week 12) and 3-month post-trial 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. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.

4 secondary outcomes

Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
Time frame: 12 weeks postpartum
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Time frame: baseline to 12 weeks
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Time frame: baseline to 12 weeks
Salivary Progesterone Concentrations
Time frame: week 2, week 6, week 10, week 12

Results and safety

Results posted to the registry on 12 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	25	21
Progesterone	25	19

Primary outcome: Mean Number of Days Per Week of Cocaine Use

Time frame: Weekly measurements, Baseline to 12 weeks. Mean (Standard Deviation). Unit: number of days per week of cocaine use

Measure	Placebo n = 25	Progesterone n = 25
Baseline	0.41 (0.91)	1.15 (3.84)
Week 1	0.43 (0.88)	1.01 (3.15)
Week 2	0.45 (0.89)	0.89 (2.51)
Week 3	0.47 (0.91)	0.78 (2.16)
Week 4	0.49 (0.94)	0.68 (1.87)
Week 5	0.52 (1.02)	0.60 (1.62)
Week 6	0.52 (1.13)	0.53 (1.41)
Week 7	0.56 (1.30)	0.46 (1.18)

Placebo vs Progesterone: Risk Ratio (RR): 1.19 (95% CI 1.04 to 1.36), p = 0.010, Generalized Estimating Equation

Population analysed: intent-to-treat

Primary outcome: Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up

Time frame: baseline, end of trial (week 12), 3-month post-trial follow-up. Mean (95% Confidence Interval). Unit: days of cocaine use between visits

Measure	Placebo n = 25	Progesterone n = 25
Baseline	0.5200 (0.1419 to 1.9062)	1.6800 (0.5983 to 4.7171)
End of Trial (Week 12)	0.2860 (0.1237 to 0.6609)	0.05550 (0.009978 to 0.3087)
3-Month Post-Trial Follow-Up	12.8472 (5.3751 to 30.7066)	1.3659 (0.2618 to 7.1263)

Placebo vs Progesterone: Risk Ratio (RR): 30.39 (95% CI 3.18 to 290.04), p = 0.003, Generalized Estimating Equation
Placebo vs Progesterone: Risk Ratio (RR): 16.65 (95% CI 1.18 to 235.52), p = 0.038, Generalized Estimating Equation

Population analysed: intent-to-treat

Primary outcome: Proportion of Positive Urine Samples Per Week

Time frame: weekly measurements, baseline to 12 weeks. Mean (95% Confidence Interval). Unit: proportion of positive urines per week

Measure	Placebo n = 25	Progesterone n = 25
Baseline	0.2645 (0.1278 to 0.4688)	0.1990 (0.0882 to 0.3893)
Week 1	0.2667 (0.1366 to 0.4554)	0.2006 (0.0928 to 0.3810)
Week 2	0.2689 (0.1448 to 0.4443)	0.2022 (0.0969 to 0.3745)
Week 3	0.2712 (0.1519 to 0.4360)	0.2038 (0.1003 to 0.3702)
Week 4	0.2734 (0.1576 to 0.4309)	0.2054 (0.1029 to 0.3681)
Week 5	0.2757 (0.1613 to 0.4296)	0.2071 (0.1047 to 0.3685)
Week 6	0.2780 (0.1629 to 0.4323)	0.2087 (0.1054 to 0.3714)
Week 7	0.2803 (0.1623 to 0.4390)	0.2104 (0.1051 to 0.3768)

Placebo vs Progesterone: Risk Ratio (RR): 1.00 (95% CI 0.87 to 1.15), p = 0.99, Generalized Estimating Equation

Population analysed: intent-to-treat

Primary outcome: Proportion of Positive Urine Samples Per Week

Time frame: baseline, end of trial (week 12) and 3-month post-trial follow-up. Mean (95% Confidence Interval). Unit: proportion of positive urines per week

Measure	Placebo n = 25	Progesterone n = 25
Baseline	0.2400 (0.1120 to 0.4416)	0.1582 (0.0559 to 0.3733)
Week 12	0.3173 (0.1606 to 0.5303)	0.1904 (0.0758 to 0.4028)
3 month post-trial follow-up	0.3952 (0.2189 to 0.6037)	0.2246 (0.0852 to 0.4740)

Placebo vs Progesterone: Risk Ratio (RR): 1.34 (95% CI 0.23 to 7.88), p = 0.75, Generalized Estimating Equation
Placebo vs Progesterone: Risk Ratio (RR): 1.18 (95% CI 0.24 to 5.84), p = 0.84, Generalized Estimating Equation

Population analysed: intent-to-treat

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	11 of 25 (44%)	Not reported
Progesterone	0 of 25 (0%)	15 of 25 (60%)	Not reported

Limitations and caveats (from the sponsor): Women seen only once per week leading to reliance on self-reports more than urine, results of which differed; post-partum women with cocaine use disorder have other issues affecting likelihood of cocaine use; missed visits may have biased results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Research site webpageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Data request should be made to the PI

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kimberly A Yonkers, MD principal investigator

Yale University

Mehmet Sofuoglu, MD, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Progesterone in people with Cocaine Abuse and Cocaine Dependence, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Days Per Week of Cocaine Use (time frame: Weekly measurements, Baseline to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01249274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017; AzTrials last refreshed its copy on 27 Oct 2026.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (3 listed)

Key exclusion criteria (12 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Mean Number of Days Per Week of Cocaine Use

Primary outcome: Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up

Primary outcome: Proportion of Positive Urine Samples Per Week

Primary outcome: Proportion of Positive Urine Samples Per Week

Adverse events

Research links

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Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Mean Number of Days Per Week of Cocaine Use

Primary outcome: Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up

Primary outcome: Proportion of Positive Urine Samples Per Week

Primary outcome: Proportion of Positive Urine Samples Per Week

Adverse events