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Opioid Partial Agonist

Injectable Buprenorphine for Methamphetamine Use Disorder (CTN-0110 Trial)

Phase 2

Recruiting

Led By Madhukar Trivedi, MD

Research Sponsored by Madhukar H. Trivedi, MD

Eligibility Criteria Checklist

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

Must have

Be 18 to 65 years of age, inclusive;

Able to understand and speak English or Spanish

Must not have

Have a surgery planned or scheduled, or other treatment that would require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;

If biologically female, be currently pregnant, breastfeeding, or planning on conception;

Timeline

Screening 7 days

Treatment 12 weeks

Follow Up 1 month

Summary

This trial tests if a medication can help with Meth use disorder, with mild opioid use.

Who is the study for?

This trial is for adults aged 18-65 with methamphetamine use disorder and mild opioid use, who want to reduce or stop using methamphetamine. Participants must speak English or Spanish, not be on certain medications, have no severe liver or kidney issues, and women must agree to contraception and pregnancy testing.

What is being tested?

The study compares a monthly injectable buprenorphine (BUP-Inj) against a placebo injection over 12 weeks in individuals with methamphetamine abuse/addiction and mild co-use of opioids. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine.

What are the potential side effects?

Possible side effects of BUP-Inj may include reactions at the injection site, nausea, headache, dizziness, fatigue or allergic reactions like anaphylaxis. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I can understand and speak English or Spanish.

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I have passed a drug test for opioids during screening and on the day I expect to join the trial.

Exclusion Criteria

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

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I am scheduled for surgery or treatment that will need opioid painkillers.

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I am currently pregnant, breastfeeding, or planning to become pregnant.

Timeline

Screening ~ 7 days3 visits

Treatment ~ 12 weeks24 visits

Follow Up ~ 1 month1 visit

Screening ~ 7 days

Treatment ~ 12 weeks

Follow Up ~1 month

This trial's timeline: 7 days for screening, 12 weeks for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of MA-negative UDS results obtained

Secondary study objectives

Number of days of MA and opioid co-use during the medication phase

Number of days of methamphetamine use during the medication phase

Number of days of opioid use during the medication phase

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Injectable Buprenorphine (BUP-inj)Experimental Treatment1 Intervention

Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks

Group II: Injectable Placebo (PBO-inj)Placebo Group1 Intervention

Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.

0 / 5Eligibility criteria met