Contingency Management for Methamphetamine Use and STIs

(IMSTI Trial)

Overseen By Cherie Blair, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Opioids, Cocaine, Hallucinogens

Disqualifiers: Other substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how reducing methamphetamine use affects certain health markers and risky behaviors related to HIV and other sexually transmitted infections (STIs). It specifically examines changes in inflammation levels and the interaction between meth use and STIs. All participants will receive contingency management, a behavioral therapy where they earn rewards for abstaining from meth. This trial suits cisgender men who regularly use methamphetamine and have recently engaged in unprotected anal sex. Participants must provide samples and complete surveys over an 8-week period. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative health solutions.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently being treated for another substance use disorder, you would not be eligible to participate.

What prior data suggests that contingency management is safe for reducing methamphetamine use?

Research has shown that contingency management is a well-accepted treatment for methamphetamine use disorder. This method uses rewards to help people stay off drugs. Studies have found it works well, especially for those using stimulants like methamphetamine. Reports indicate that participants usually do not experience serious side effects in these programs, making it a promising option for those wanting to reduce methamphetamine use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contingency management for methamphetamine use because it offers a behavioral approach rather than relying on medication. Unlike traditional treatments that focus on counseling or pharmacotherapy, this method incentivizes abstinence by providing tangible rewards for clean drug tests. This positive reinforcement can be a powerful motivator for individuals struggling with addiction, offering a fresh and promising angle to tackle methamphetamine dependence and associated issues like STIs.

What evidence suggests that contingency management is effective for reducing methamphetamine use?

Research has shown that contingency management, the method used in this trial, can help reduce methamphetamine use. This approach involves giving rewards to individuals who demonstrate they are not using the drug. Studies have found that this method helps individuals adhere to their treatment plans and reduce drug use. For methamphetamine users, proving they are drug-free can lead to positive behavioral changes. This method has been successful for those with methamphetamine addiction and shows promise as a treatment strategy. ^{6 7 8 9 10}

Who Is on the Research Team?

Cherie Blair

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for cisgender male methamphetamine users aged 18-45 who have had unprotected intercourse with an HIV-positive or unknown status partner in the last 90 days. Participants must be HIV-negative, understand English, and meet criteria for methamphetamine use disorder. Half need a positive test for rectal gonorrhea/chlamydia; the other half negative. Those on treatment for other substance disorders or testing positive for certain drugs are excluded.

Inclusion Criteria

I am a cisgender male.

Meet DSM-5 criteria for methamphetamine use disorder

Positive urine toxicology screen for methamphetamine metabolites at study entry

Exclusion Criteria

Reports current treatment for another substance use disorder

Positive test for opioids, cocaine, and/or hallucinogens

Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Initial assessment of methamphetamine use, rectal inflammatory cytokine levels, and STI status

1 week

Treatment

Participants receive contingency management intervention for methamphetamine reduction

8 weeks

Weekly visits for behavioral surveys, urine drug testing, and rectal sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview

The study tests if reducing methamphetamine use through Contingency Management affects inflammation in the rectum and lowers risky behaviors related to HIV/STI transmission among men who have sex with men (MSM). It will compare those with and without rectal infections over 8 weeks using behavioral surveys, drug testing, and cytokine level measurements.

How Is the Trial Designed?

Group I: Contingency management Experimental Treatment 1 Intervention

All enrolled participants will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.

Contingency Management is already approved in United States, European Union for the following indications:

Approved in United States as Contingency Management for:

• Substance Use Disorders
• Stimulant Use Disorder
• Methamphetamine Use Disorder

Approved in European Union as Contingency Management for:

• Substance Use Disorders
• Addiction Treatment

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 255 substance users undergoing outpatient treatment, participants who were drug-free at the start (baseline negative) earned significantly more in contingency management (CM) incentives compared to those who were using drugs (baseline positive), with median prizes of $237 versus $44, respectively.

The findings suggest that tailoring CM interventions based on a participant's drug use status at treatment entry could enhance the effectiveness of abstinence-focused programs, as the majority of incentive expenditures were directed towards those who were already abstinent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. Cunningham, C., Stitzer, M., Campbell, AN., et al.[2019]

A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.

Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

A study involving 110 HIV-positive sexual minority men showed that a positive affect intervention, when combined with contingency management (CM), significantly increased positive feelings and mindfulness over three months.

Participants who received the positive affect intervention experienced reduced cravings for methamphetamine and reported lower stimulant use, suggesting that enhancing emotional well-being can improve treatment outcomes in substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. Carrico, AW., Gόmez, W., Jain, J., et al.[2023]

In a study involving 127 men who have sex with men (MSM) using methamphetamine, a 12-week contingency management (CM) intervention did not significantly reduce methamphetamine use compared to a minimal intervention control group.

Although retention in the study was high at 84%, participants receiving CM were more likely to report increased methamphetamine use during and after the intervention, suggesting that CM may not lead to sustained reductions in drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. Menza, TW., Jameson, DR., Hughes, JP., et al.[2022]

A low-cost contingency management (CM) procedure significantly improved continuous abstinence from cocaine and opioids among 42 methadone patients over a 12-week treatment period, compared to standard treatment alone.

Patients in the CM group not only achieved longer periods of abstinence but also maintained these effects for 6 months after treatment, earning an average of $137 in prizes, indicating the potential effectiveness of this approach in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-cost contingency management for treating cocaine- and opioid-abusing methadone patients. Petry, NM., Martin, B.[2019]

Contingency management (CM) is highly effective in reducing methamphetamine use, as shown in a systematic review of 27 studies, with 20 out of 21 studies reporting positive outcomes for drug abstinence.

CM not only increases drug abstinence but also enhances the use of other treatments and medical services, while significantly reducing risky sexual behaviors among methamphetamine users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for the treatment of methamphetamine use disorder: A systematic review. Brown, HD., DeFulio, A.[2021]

A pilot study on methamphetamine-dependent individuals indicates that using a reinforcement schedule that increases rewards for consecutive days of abstinence leads to better outcomes.

The study found that resetting the reward magnitude after a positive drug test enhances the effectiveness of contingency management interventions, suggesting a strategic approach to reinforcing abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: schedule effects. Roll, JM., Shoptaw, S.[2013]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

In a study involving 74 cocaine-dependent methadone outpatients over 12 weeks, both voucher and prize-based contingency management (CM) interventions led to longer durations of abstinence compared to standard treatment.

The study found no significant differences in outcomes between the voucher and prize systems, indicating that both methods are effective in promoting abstinence during treatment, which is linked to better long-term recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. Petry, NM., Alessi, SM., Hanson, T., et al.[2021]

Contingency management has been identified as a potentially effective approach for treating methamphetamine use disorders, as it can enhance treatment outcomes.

The evidence indicates that this method increases the chances of patients providing methamphetamine-free urine samples during treatment, suggesting improved adherence to recovery efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: an evidence-based component of methamphetamine use disorder treatments. Roll, JM.[2019]

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