Contingency Management for Methamphetamine Use in HIV/AIDS

(EXPRESS+ Trial)

Overseen By Michael J Li, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Antiretrovirals

Disqualifiers: Female, 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: 21

Duration: 8 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a rewards-based approach, called contingency management (also known as Motivational Incentives or the Prize Method), can help reduce methamphetamine use in people with HIV. The study offers increasing rewards for negative drug tests over eight weeks to participants using methamphetamine. Participants must be HIV-positive, assigned male at birth, currently using methamphetamine, and seeking treatment. A non-substance-using group serves as a comparison and does not receive any intervention. The goal is to determine if reducing meth use can impact inflammation, immune response, and viral load in these individuals. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative treatment approaches for methamphetamine use in HIV-positive individuals.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have a current antiretroviral prescription to participate.

What prior data suggests that Contingency Management is safe for reducing methamphetamine use in HIV-positive individuals?

Studies have shown that contingency management safely and effectively helps people reduce methamphetamine use. This method uses rewards to encourage drug-free behavior. Research indicates that this approach is well-tolerated for treating substance use disorders, with no reports of serious side effects. It involves giving small rewards, such as money, for negative drug tests. This positive reinforcement has successfully helped people reduce drug use without harming their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the contingency management approach for reducing methamphetamine use in individuals with HIV/AIDS because it offers a behavioral intervention rather than a pharmacological one. Unlike traditional treatments that often focus on medication-assisted therapy, contingency management uses positive reinforcement, rewarding participants with increasing incentives for negative drug tests. This method not only encourages immediate behavior change but also provides motivation for continued abstinence, creating a potentially powerful tool for reducing methamphetamine use and supporting overall health in people with HIV/AIDS.

What evidence suggests that Contingency Management is effective for reducing methamphetamine use in HIV-positive individuals?

Research has shown that contingency management (CM), which participants in this trial may receive, effectively treats methamphetamine addiction. CM rewards individuals who abstain from drug use, and it has greatly reduced methamphetamine use. Studies indicate that CM is a leading treatment for stimulant addictions, including methamphetamine. Additionally, it has helped individuals with HIV adhere to their antiretroviral therapy (ART). Overall, CM is among the most successful methods for reducing methamphetamine use and improving health. ^{2 5 6 7 8}

Who Is on the Research Team?

Michael J Li, PhD

Principal Investigator

UCLA Department of Family Medicine

Are You a Good Fit for This Trial?

This trial is for HIV-positive males aged 18-45 who have sex with men and are seeking treatment for methamphetamine use disorder. Participants must be on antiretroviral therapy, test positive for meth within 30 days before screening, and can attend bi-weekly appointments. Those using opioids, cocaine, MDMA or identifying as female cannot join.

Inclusion Criteria

I am a male, aged 18-45, HIV-positive, have sex with men, and am on antiretroviral treatment.

Exclusion Criteria

I am a female who has used substances like meth, opioids, cocaine, or MDMA in the last 6 months.

I identify as female, have a substance use disorder, and may be in another trial or tested positive for certain drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the contingency management group receive treatment for methamphetamine use disorder with escalating rewards for negative urine tests

8 weeks

16 visits (in-person, twice weekly)

Observation

Non-substance-using control group participants have observational visits

12 weeks

4 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for changes in methamphetamine use, viral load, and gene expression

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview The EXPRESS+ study examines if changes in stress markers align with shifts in meth use and viral load over a period of 12 weeks among HIV-positive individuals assigned male at birth who do or don't have a methamphetamine use disorder.

How Is the Trial Designed?

Group I: Contingency Management for Methamphetamine Reduction Experimental Treatment 1 Intervention

8 weeks of contingency management, twice weekly visits, with escalating rewards from $10 to $40 for negative urine tests

Group II: Non-substance-using Control Active Control 1 Intervention

Observational visits (no intervention) at baseline, Week 4, Week 8, and Week 12 for those who do not use methamphetamine.

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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a 16-week study involving 12 cocaine-dependent methadone patients, cash-based incentives of $50 and $100 significantly increased short-term cocaine abstinence compared to a control condition with no incentives.

The study found that cash-based incentives did not lead to increased cocaine use after receiving the incentives, suggesting they are a safe option for improving treatment outcomes in substance abuse interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management in cocaine abusers: a dose-effect comparison of goods-based versus cash-based incentives. Vandrey, R., Bigelow, GE., Stitzer, ML.[2022]

A study involving 110 sexual minority men living with HIV showed that increasing positive affect during a contingency management intervention helped reduce stimulant use and maintain lower HIV viral loads over 15 months.

The research found that lower stimulant use was a key factor in achieving long-term reductions in HIV viral load, highlighting the need for sustained interventions targeting stimulant use to enhance HIV treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An autoregressive cross-lagged model unraveling co-occurring stimulant use and HIV: Results from a randomized controlled trial. Lee, JY., Lee, JE., Moskowitz, JT., et al.[2022]

Providers at treatment sites that implemented contingency management (CM) programs had more positive opinions about these programs compared to matched providers at sites that did not implement CM, especially when accounting for their experience with tangible incentives.

The study suggests that exposure to CM programs can positively influence provider attitudes, which may help in promoting the adoption of these effective interventions in community treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is exposure to an effective contingency management intervention associated with more positive provider beliefs? Kirby, KC., Carpenedo, CM., Stitzer, ML., et al.[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 95 methadone-maintenance patients, a contingency management approach that rewarded gradual reductions in cocaine use (shaping group) led to lower cocaine use compared to a standard abstinence-based approach, particularly in the final 5 weeks of the 8-week intervention.

The study also found that once patients achieved abstinence through escalating-value vouchers, they could maintain this abstinence with a simpler, nonescalating reward schedule, indicating that contingency management can be an effective long-term treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shaping cocaine abstinence by successive approximation. Preston, KL., Umbricht, A., Wong, CJ., et al.[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 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]

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]

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]

In a study involving 113 participants with methamphetamine use disorders, those who received contingency management alongside standard treatment submitted significantly more negative drug tests and maintained abstinence for longer periods (5 weeks) compared to those receiving only standard treatment (3 weeks).

The use of contingency management, which involved rewards for negative drug tests, shows potential as an effective strategy to enhance treatment outcomes for individuals struggling with methamphetamine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for the treatment of methamphetamine use disorders. Roll, JM., Petry, NM., Stitzer, ML., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12402737/

Harm Reduction Contingency Management for Stimulant Use ... Contingency management (CM) is the first-line treatment for stimulant (methamphetamine and cocaine) use disorder and has also been used to promote ART adherence ...

2. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf Contingency management (CM) is a proven health care intervention with demonstrated effectiveness in treating a variety of substance use disorders (SUDs) ...

3. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/a0cc6fcdb2968be95f60bb1c2c94eb70/contingency-management-sub-treatment.pdf

Contingency Management for the Treatment of Substance ... Between 2020 and 2021, the rate of deaths involving psychostimulants with abuse potential, such as methamphetamine, increased 34% -- a more ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330855/

Implementing an evidence-based prize contingency ... This article provides planning stage guidance to support programs' adoption of evidence-based prize CM for the treatment of stimulant use disorders. Keywords: ...

5. researchgate.net researchgate.net/publication/392448330_Harm_reduction_contingency_management_for_stimulant_use_reduction_and_ART_adherence_in_HIV_primary_care_an_implementation-effectiveness_study_protocol_Preprint

Harm reduction contingency management for stimulant use ... Contingency management is among the most effective interventions for reducing methamphetamine use. ... HIV Who Use Cocaine or Opiates. April ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7252223/

Optimizing Contingency Management with ... Contingency management (CM) is an evidence-based, behavioral intervention implemented to curb methamphetamine use and optimize HIV/AIDS prevention among MSM in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6420845/

Interventions to reduce drug use among methamphetamine ... These results indicate that incentive-based interventions with case management may be useful for helping meth users reduce their drug use.

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825005153

Harm Reduction Contingency Management for Stimulant ... Stimulant use disorder has been linked with medication nonadherence and mortality among people living with HIV. Contingency management (CM) ...