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Cocaine DependencePhase 2/3PROGNCT00632099

Progesterone Treatment for Cocaine-dependent Women: A Pilot Study

A Phase 2/3 study testing Oral micronized progesterone in people with Cocaine Dependence, run by New York State Psychiatric Institute 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 purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans \& Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preliminary data… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Cocaine Dependence
What is being tested?
Oral micronized progesterone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
Feb 2008to Sep 2012
Phase
Phase 2/3
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 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. Women between the ages of 18-60 who meet criteria for current cocaine dependence (DSM-IV-TR). Volunteers may meet criteria for abuse or dependence on nicotine, marijuana or alcohol, as long as the dependence is secondary to cocaine dependence and does not require any medical intervention (see additional exclusions for alcohol dependence below).
  • 2. Use cocaine by the smoked or intranasal route at least four days in the past month, with at least weekly cocaine use.
  • 3. Women with regular menstrual cycles (24-45 days) who are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must agree to use a barrier method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be conducted weekly.
  • 4. Women must be capable of giving informed consent and capable of complying with study procedures.

Who cannot join

  • 1. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse.
  • 2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable or would be disrupted by study medication. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon or other medications for insomnia if there is no evidence of dependence on these substances.
  • 3. Individuals with current major depressive disorder.
  • 4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) that require medical intervention will be excluded and referred for treatment. Individuals with severe alcohol dependence , even without physiological dependence, or with any known alcohol-related diseases will also be excluded.
  • 5. Females who have any of the following medical contraindications: undiagnosed abnormal genital bleeding, known or suspected history of breast or genital cancer, active deep vein thrombosis, pulmonary embolism, or history of these conditions, active or recent (within last year) arterial thromboembolic diseases (e.g., stroke, myocardial infarction), liver dysfunction.
  • 6. Females who are cognitively impaired or have a chronic organic mental disorder.
Show all 13Show fewer
  • 7. Individuals with current suicidal risk.
  • 8. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.
  • 9. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (Blood pressure > 150/ 90, or Heart Rate > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 3x upper limit of normal are acceptable), or uncontrolled diabetes.
  • 10. Individuals with a history of seizures.
  • 11. Women who are pregnant or nursing.
  • 12. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
  • 13. Females with a known or suspected hypersensitivity to oral micronized progesterone.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans \& Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preliminary data indicating that oral micronized PROG also reduces smoked cocaine self-administration in the laboratory, PROG appears to be an ideal potential candidate medication to evaluate in cocaine-dependent women. Prior to randomization to treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of the primary outcome measures will be time to cocaine relapse.

Read the detailed description

Primary Aims: The primary aims will be directed at treatment efficacy. Relatively unique to cocaine treatment trials, one of the principal outcome measures will be time to cocaine relapse. We hypothesize that maintenance on PROG will increase the time to cocaine relapse compared to maintenance on placebo (PBO). Another cocaine-related efficacy endpoint will be the proportion of patients who achieve at least 2 consecutive weeks of cocaine abstinence (based on urine toxicology results) during the double-blind treatment phase. Lastly, the proportion of cocaine-negative urines collected throughout the treatment trial will be measured. We hypothesize that women in the PROG group will show a greater reduction in cocaine use compared to those in the PBO group.

Secondary Aims: 1) Determine if response to laboratory stressors will predict treatment outcome. We hypothesize that those women with the greatest stress response will do worse in treatment and that maintenance on PROG will reduce stress/anxiety and thereby improve treatment outcome. 2) Determine if treatment retention is better in the PROG group compared to the PBO group and determine if maintenance on PROG improves overall functioning compared to maintenance on PBO based on the Clinical Global Inventory (CGI). We hypothesize that women in the PROG group will have better treatment retention and improvement in CGI scores compared to women in the PBO group.

Tertiary Aims: To conduct exploratory analyses to determine whether 1) trauma history is related to treatment outcomes and 2) improvements in treatment outcome measures are related to decreases in HIV high-risk behaviors.

Being tested
Oral micronized progesterone, Placebo
Keywords
cocaine, treatment, progesterone
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.

  • Oral micronized progesteroneDrug

    Also called Progesterone

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

  • PlaceboDrug

    matched placebo

Study groups in NCT00632099
Study groupRoleWhat they receive
PlaceboPlacebo comparatormatched placebo
Receives: Drug: Placebo
Oral micronized progesteroneExperimentalOral micronized progesterone (up to 400 mg/day)
Receives: Drug: Oral micronized progesterone

What is being measured

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

  1. Cocaine Abstinence Based on Urine Toxicology Results

    Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)

    Measured: during last 3 weeks of the trial

Timeline

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

  1. First posted10 Mar 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632099
Sponsor's protocol ID
#5568
Other IDs
R01DA022218, DPMCDA
Acronym
PROG
Status last verified
Apr 2014
First submitted
6 Mar 2008
Last updated
12 May 2014
Data monitoring committee
Yes

Publications

  • Oliva A, Reed SC, Brooks DJ, Levin FR, Evans SM. Safety and tolerability of progesterone treatment for women with cocaine use disorder: a pilot treatment trial. Am J Drug Alcohol Abuse. 2022 Sep 3;48(5):586-595. doi: 10.1080/00952990.2022.2114004. Epub 2022 Sep 12.

    PubMed 36095308

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral micronized progesterone in people with Cocaine Dependence, run by New York State Psychiatric Institute 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 4 inclusion and 13 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 12 May 2014. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2014). 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?

Cocaine Abstinence Based on Urine Toxicology Results (time frame: during last 3 weeks of the trial). 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 NCT00632099, which also lists 1 linked publication.

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 12 May 2014.

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