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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.

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 data supports the effectiveness of the treatment Contingency Management for methamphetamine use and STIs?

Research shows that Contingency Management, which uses rewards to encourage positive behavior, is effective in reducing methamphetamine use and risky sexual behavior. Studies have found that it leads to greater drug abstinence and higher use of other treatments, making it a promising approach for treating methamphetamine use disorder. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management, which involves giving rewards for positive behavior like drug abstinence, has been studied in various settings and appears to be safe for humans. It has been used successfully in treating methamphetamine use and other substance use disorders without reported safety concerns. ^{1 5 6 7 8}

How is the Contingency Management treatment different from other treatments for methamphetamine use?

Contingency Management is unique because it uses rewards to encourage abstinence from methamphetamine, offering incentives like vouchers or prizes when drug-free tests are confirmed. This approach is different from other treatments as it directly ties positive reinforcement to drug-free behavior, which has been shown to effectively reduce drug use and risky behaviors. ^{1 3 9 10 11}

Research Team

Cherie Blair

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]

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

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. [2021]

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

Examining implementation of contingency management in real-world settings. [2021]

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

Low-cost contingency management for treating cocaine- and opioid-abusing methadone patients. [2019]

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

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. [2019]

7. England 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. [2022]

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

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

9. Ireland pubmed.ncbi.nlm.nih.gov

Contingency management: schedule effects. [2013]

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

Contingent Vs. Non-Contingent Rewards: Time-Based Intervention Response Patterns Among Stimulant-Using Men Who Have Sex With Men. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a positive affect intervention for methamphetamine users. [2023]