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

Trial Summary

What is the purpose of this trial?

This is a non-randomized behavioral trial that aims to investigate whether changes in inflammatory and type I IFN expression coincide with changes in methamphetamine use and viral load over the course of 12 weeks in HIV-positive people assigned male at birth with and without methamphetamine use disorder.

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 data supports the effectiveness of the treatment Contingency Management for Methamphetamine Use in HIV/AIDS?

Research shows that Contingency Management, which uses rewards like vouchers or prizes to encourage drug abstinence, has been effective in reducing cocaine and opioid use among methadone patients. Patients in these programs achieved longer periods of abstinence, suggesting that similar methods could help reduce methamphetamine use in individuals with HIV/AIDS. ^{1 2 3 4 5}

Is Contingency Management safe for humans?

Contingency Management, which uses rewards to encourage positive behavior, has been studied for various substance use disorders and generally shows no significant safety concerns. Studies have shown it to be effective in reducing drug use and risky behaviors without increasing drug use when cash incentives are used. ^{2 6 7 8 9}

How is the treatment Contingency Management different from other treatments for methamphetamine use in HIV/AIDS?

Contingency Management is unique because it uses rewards to encourage people to stop using methamphetamine, which can lead to greater drug abstinence and reduced risky behaviors. Unlike other treatments, it directly ties positive behavior changes to tangible incentives, making it particularly effective in outpatient settings. ^{9 10 11 12 13}

Research Team

Michael J Li, PhD

Principal Investigator

UCLA Department of Family Medicine

Eligibility Criteria

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.

Contingency Management: Assigned male sex at birth, 18 to 45 years of age, Reports having sex with men in the past 12 months, HIV-positive, Has an HIV care provider, Has a current antiretroviral prescription, Meets the DSM-5 criteria for methamphetamine use disorder using SCID-5, Urine test is positive for methamphetamine within 30 days of their screening visit, Seeking treatment for methamphetamine use disorder, Ability to attend twice weekly appointments for drug testing and 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

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

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

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

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

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

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

Shaping cocaine abstinence by successive approximation. [2019]

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

Is exposure to an effective contingency management intervention associated with more positive provider beliefs? [2021]

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

Contingency management in cocaine abusers: a dose-effect comparison of goods-based versus cash-based incentives. [2022]

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

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

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

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

10. Ireland pubmed.ncbi.nlm.nih.gov

An autoregressive cross-lagged model unraveling co-occurring stimulant use and HIV: Results from a randomized controlled trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

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

12. Ireland pubmed.ncbi.nlm.nih.gov

Contingency management: schedule effects. [2013]

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

Contingency management for the treatment of methamphetamine use disorders. [2022]