What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of methamphetamine addiction. Research is ongoing, including trials like the one studying micronized progesterone for its potential to prevent methamphetamine use through hormonal regulation. Other treatments under investigation include various psychostimulants and behavioral therapies, but none have received FDA approval specifically for methamphetamine addiction.

What other types of research exist?

Promising novel alternatives to micronized progesterone for methamphetamine addiction treatment include: 1) N-acetylcysteine (NAC), which has shown potential in reducing cravings and improving cognitive function; 2) Bupropion, an atypical antidepressant that may help reduce methamphetamine use by modulating dopamine levels; 3) Varenicline, typically used for smoking cessation, which has shown promise in reducing methamphetamine cravings and use; and 4) Cognitive-behavioral therapy (CBT) combined with contingency management, which has been effective in reducing substance use and improving treatment adherence.

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Progesterone for Methamphetamine Addiction in Postpartum Women

Q: What is the mechanism of action of this treatment?

Micronized progesterone, being studied for methamphetamine addiction, works by modulating the hormonal environment, potentially reducing cravings and preventing relapse. Progesterone may influence the brain's reward system and stress response, which are often dysregulated in addiction. This hormonal regulation is crucial for methamphetamine addiction patients as it offers a novel approach to managing cravings and reducing the likelihood of relapse, addressing both the physiological and psychological aspects of addiction. Other common treatments include behavioral therapies and medications like bupropion, which target neurotransmitter systems to reduce cravings and withdrawal symptoms.

Q: What side effects are associated with this type of intervention?

Micronized progesterone, currently being studied for methamphetamine addiction, is generally well-tolerated but can cause side effects such as dizziness, headache, mood swings, and gastrointestinal issues. Other common treatments for methamphetamine addiction include behavioral therapies and medications like bupropion and naltrexone. Bupropion can cause insomnia, dry mouth, and increased heart rate, while naltrexone may lead to nausea, headache, and dizziness. It's important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

Phase < 1

Waitlist Available

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No active methamphetamine use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology

Be older than 18 years old

Must not have

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

Severe depressive symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months after study initiation

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Progesterone may cause mood swings, headaches, bloating, breast tenderness, changes in menstrual flow or sleep patterns. The side effects vary from person to person and some might not experience any noticeable issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not used methamphetamine in the last 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing severe depression.

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I am currently using medications that contain progestin.

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I have a history of severe mental health issues, including psychosis or hospitalizations.

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I do not speak English or Spanish.

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I am not taking strong medications like clarithromycin or ketoconazole.

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I do not have major illnesses where progesterone is not advised.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months after study initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months after study initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months after study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful recruitment and randomization of 40 postpartum women into the PROMPT study

Secondary study objectives

Assess anxiety status in enrolled participants

Assess breastfeeding difficulty in enrolled participants

Assess depression and suicidality status in enrolled participants

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Progesterone ArmActive Control1 Intervention

Randomized to receive progesterone

Group II: Placebo ArmPlacebo Group1 Intervention

Randomized to receive placebo

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Micronized progesterone, being studied for methamphetamine addiction, works by modulating the hormonal environment, potentially reducing cravings and preventing relapse. Progesterone may influence the brain's reward system and stress response, which are often dysregulated in addiction. This hormonal regulation is crucial for methamphetamine addiction patients as it offers a novel approach to managing cravings and reducing the likelihood of relapse, addressing both the physiological and psychological aspects of addiction. Other common treatments include behavioral therapies and medications like bupropion, which target neurotransmitter systems to reduce cravings and withdrawal symptoms.

Methamphetamine administration during gestation impairs maternal behavior.Time-course of methamphetamine-induced neurotoxicity in rat caudate-putamen after single-dose treatment.