Progesterone for Methamphetamine Addiction in Postpartum Women

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether progesterone can help new mothers avoid returning to methamphetamine use. Participants will receive either progesterone or a placebo (a pill with no active medicine) for 12 weeks. The study aims to determine if progesterone is safe and effective in reducing meth cravings and preventing relapse. Women who recently gave birth, have struggled with meth use in the past, but have not used it for the last four weeks might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how progesterone works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that progesterone, the treatment being tested in this trial, is usually well-tolerated. Other studies have reported its use for various health issues without major safety concerns. Progesterone, a hormone naturally produced by the body, is often used in medical treatments. Some individuals might experience mild side effects, such as headaches or mood changes, but serious problems are rare. As this trial is in an early stage, it primarily focuses on ensuring the treatment's safety and determining the optimal dose. The researchers are taking extra care to monitor participants' responses to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for methamphetamine addiction?

Researchers are excited about progesterone for treating methamphetamine addiction in postpartum women because it offers a new approach that targets hormonal pathways. Unlike current treatments, which mainly focus on behavioral therapies and support groups, progesterone may help stabilize mood and reduce cravings by interacting with the brain's reward system. This unique mechanism of action could provide a more direct biological intervention, potentially leading to more effective management of addiction symptoms.

What evidence suggests that progesterone might be an effective treatment for methamphetamine addiction in postpartum women?

Research has shown that progesterone, which participants in this trial may receive, might help reduce cravings and methamphetamine use, particularly in women who have recently given birth. Studies suggest that progesterone can help balance hormones affecting mood and addiction. It likely works by increasing a calming chemical in the brain, which may help control cravings. Although data remains limited, early results are promising for using progesterone to prevent methamphetamine use. This approach aims to offer new support for postpartum women dealing with addiction. ^{1 2 5 6 7}

Who Is on the Research Team?

Marcela Smid, MD

Principal Investigator

University of Utha

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415636/

Prevention of postpartum methamphetamine use with ... While most pregnant individuals with methamphetamine use disorder (MUD) achieve abstinence, the postpartum period remains a vulnerable time ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05128071

PRevention Of Methamphetamine Use Among Postpartum ... Assess the efficacy of micronized progesterone to decrease return to methamphetamine use (MU) among postpartum women with methamphetamine use disorder.

3. withpower.com withpower.com/trial/early-phase-1-10-2021-4caa3

Progesterone for Methamphetamine Addiction in ... Trial Overview This study tests if taking oral micronized progesterone twice daily can help prevent returning to methamphetamine use in postpartum women ...

4. researchgate.net researchgate.net/publication/383835457_Prevention_of_postpartum_methamphetamine_use_with_micronized_progesterone_trial_PROMPT_A_pilot_randomized_controlled_trial_protocol

A pilot randomized controlled trial protocol Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol. August ...

5. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/b6c3761c-7a54-4ea0-91cd-75ea9ac80496-MECA.pdf?abstractid=4733261

Prevention of postpartum methamphetamine use with ... KEYWORDS: Postpartum period; methamphetamine; substance use disorder; progesterone;. 53 randomized controlled trial. 54. Clinical Trial Registration Number ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39308801/

A pilot randomized controlled trial protocol - PubMed - NIH Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol · Abstract.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05128071/prevention-of-methamphetamine-use-among-postpartum-women-trial-prompt

PRevention Of Methamphetamine Use Among Postpartum ... The aims of this study are to assess the feasibility, safety and preliminary efficacy of micronized progesterone for the prevention of return to methamphetamine ...