Progesterone for Methamphetamine Addiction in Postpartum Women

Recruiting at -1 trial locations

Overseen By Kristi Carlston

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Utah

Must be taking: Methadone, Buprenorphine, Naltrexone

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, others

Disqualifiers: Liver disease, Heart disease, Psychosis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether taking progesterone can help postpartum women avoid returning to methamphetamine use. Postpartum women are chosen because they are at high risk of relapse. Progesterone may help by reducing drug cravings, making it easier to stay off methamphetamine. Progesterone has been studied for various uses, including reducing breast pain and preventing preterm birth.

Do I need to stop my current medications to join the trial?

The trial requires you to stop taking certain medications, including stimulants, barbiturates, benzodiazepines, and some others, two weeks before joining. However, you can stay on stable doses of certain psychiatric medications and medications for opioid use disorder.

What data supports the effectiveness of the drug for methamphetamine addiction in postpartum women?

Research suggests that progesterone, a component of the treatment, may reduce cravings and the euphoric effects of drugs, showing potential as a treatment for substance use disorders. Studies have shown that progesterone can decrease drug-seeking behaviors and cravings in both men and women, indicating its promise for treating addictions. ^{1 2 3 4 5}

Is progesterone safe for treating substance use disorders?

Progesterone has been shown to be safe and well-tolerated in clinical trials for women with cocaine use disorder, with common side effects being headache and fatigue. It has also been tested in men and women for various substance use disorders, showing promising safety results. ^{2 3 4 6 7}

How does progesterone differ from other drugs for methamphetamine addiction in postpartum women?

Progesterone is unique because it modulates brain functions related to addiction and has shown potential in reducing drug use in women, particularly during high progesterone states. Unlike other treatments, it may offer a hormonal approach to managing addiction, which is especially relevant for postpartum women experiencing hormonal changes. ^{2 3 7 8 9}

Research Team

Marcela Smid, MD

Principal Investigator

University of Utha

Eligibility Criteria

The PROMPT trial is for postpartum individuals who have struggled with methamphetamine use but haven't used it in the last 4 weeks. They should be within 12 weeks after giving birth, living close to the study site, and using certain contraception methods. People with major illnesses or on medications that could interact badly with progesterone aren't eligible.

Inclusion Criteria

I have not used methamphetamine in the last 4 weeks.

I have opioid use disorder but haven't used opioids in the last 4 weeks and have been on a stable medication dose for 2 weeks.

I have been on stable doses of my psychiatric medications for at least 4 weeks.

Exclusion Criteria

I am experiencing severe depression.

I am currently using medications that contain progestin.

Any of the following laboratory abnormalities (within 2 weeks of screening and enrollment): Active hepatic dysfunction, Anemia defined as hemoglobin less than 8 g/dL indicating anemia, Renal impairment defined as creatinine greater than 2.0 mg/dL, Hypothyroidism defined as TSH greater than 5 mIU/L, Abnormal vital signs at baseline visit, Allergy to micronized progesterone or ingredients in placebo including peanut oil, gelatin or cellulose, Self-reported progestin-containing oral or depot containing contraceptives intolerance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200 mg oral micronized progesterone or placebo twice daily for 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Progesterone

Trial Overview This study tests if taking oral micronized progesterone twice daily can help prevent returning to methamphetamine use in postpartum women compared to a placebo. It also looks at how this hormone affects cravings by measuring salivary levels of allopregnanolone.

Participant Groups

Group I: Progesterone Arm Active Control 1 Intervention

Randomized to receive progesterone

Group II: Placebo Arm Placebo Group 1 Intervention

Randomized to receive placebo

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Differential effects of allopregnanolone on the escalation of cocaine self-administration and sucrose intake in female rats. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Progesterone attenuates cocaine-induced responses. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. [2013]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Role of Exogenous Progesterone in the Treatment of Men and Women with Substance Use Disorders: A Narrative Review. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A gender-based secondary analysis of the ADAPT-2 combination naltrexone and bupropion treatment for methamphetamine use disorder trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Neuroactive steroid levels and cocaine use chronicity in men and women with cocaine use disorder receiving progesterone or placebo. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of progesterone treatment for women with cocaine use disorder: a pilot treatment trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Role of progesterone in nicotine addiction: evidence from initiation to relapse. [2022]