Contingency Management for Methamphetamine Use in HIV/AIDS
(EXPRESS+ Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMichael J Li, PhD
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must be taking: Antiretrovirals
Disqualifiers: Female, Substance use disorder, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
26789How 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.
910111213Eligibility 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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Contingency Management for Methamphetamine ReductionExperimental Treatment1 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 ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA Vine Street ClinicLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. [2021]Contingency management (CM) interventions frequently utilize vouchers as reinforcers, but a prize-based system is also efficacious. This study compared these approaches. Seventy-four cocaine-dependent methadone outpatients were randomly assigned to standard treatment (ST), ST plus a maximum of $585 in contingent vouchers, or ST plus an expected average maximum of $300 in contingent prizes for 12 weeks. CM participants achieved longer durations of abstinence (LDA) than ST participants, and CM conditions did not differ significantly in outcomes or amount of reinforcement earned. Although long-term abstinence did not differ by group, LDA during treatment was the best predictor of abstinence at 9 months. Thus, reinforcement with prizes was similar to voucher CM in promoting LDA, which is associated with posttreatment benefits.
Low-cost contingency management for treating cocaine- and opioid-abusing methadone patients. [2019]This study evaluated the efficacy of a low-cost contingency management (CM) procedure in reducing concurrent cocaine and opioid use among methadone patients. Forty-two patients were randomly assigned to 12 weeks of standard treatment or standard treatment plus CM. CM patients eamed the opportunity to draw from a bowl and win prizes ranging from $1 to $ 100 in value for submitting samples negative for cocaine and opioids. Patients in the CM condition achieved longer durations of continuous abstinence than patients in the standard treatment condition, and these effects were maintained throughout a 6-month follow-up period. On average, patients in the CM condition earned $137 of prizes. These data suggest that this prize reinforcement procedure may be suitable for community-based settings.
Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]Contingency management (CM) interventions usually use vouchers as reinforcers, but a new technique awards chances of winning prizes. This study compares these approaches. In community treatment centers, 142 cocaine- or heroin-dependent outpatients were randomly assigned to standard treatment (ST), ST with vouchers, or ST with prizes for 12 weeks. CM patients remained in treatment longer and achieved greater durations of objectively confirmed abstinence than did ST patients; CM conditions did not differ significantly. Although abstinence at 6- and 9-month follow-ups did not differ by group, the best predictor of abstinence was longest duration of abstinence achieved during treatment. Thus, prize and voucher CM systems are equally efficacious in promoting long durations of abstinence, which in turn are associated with benefits posttreatment.
Shaping cocaine abstinence by successive approximation. [2019]Cocaine-using methadone-maintenance patients were randomized to standard contingency management (abstinence group, n = 49) or to a contingency designed to increase contact with reinforcers (shaping group, n = 46). For 8 weeks, both groups earned escalating-value vouchers based on thrice-weekly urinalyses: The abstinence group earned vouchers for cocaine-negative urines only; the shaping group earned vouchers for each urine specimen with a 25% or more decrease in cocaine metabolite (first 3 weeks) and then for negative urines only (last 5 weeks). Cocaine use was lower in the shaping group, but only in the last 5 weeks, when the response requirement was identical. Thus, the shaping contingency appeared to better prepare patients for abstinence. A 2nd phase of the study showed that abstinence induced by escalating-value vouchers can be maintained by a nonescalating schedule, suggesting that contingency management can be practical as a maintenance treatment.
Is exposure to an effective contingency management intervention associated with more positive provider beliefs? [2021]This study empirically examined opinions of treatment providers regarding contingency management (CM) programs while controlling for experience with a specific efficacious CM program. In addition to empirically describing provider opinions, we examined whether the opinions of providers at the sites that implemented the CM program were more positive than those of matched providers at sites that did not implement it. Participants from 7 CM treatment sites (n = 76) and 7 matched nonparticipating sites (n = 69) within the same nodes of the National Institute of Drug Abuse Clinical Trials Network completed the Provider Survey of Incentives (PSI), which assesses positive and negative beliefs about incentive programs. An intent-to-treat analysis found no differences in the PSI summary scores of providers in CM program versus matched sites, but correcting for experience with tangible incentives showed significant differences, with providers from CM sites reporting more positive opinions than those from matched sites. Some differences were found in opinions regarding costs of incentives, and these generally indicated that participants from CM sites were more likely to see the costs as worthwhile. The results from the study suggest that exposing community treatment providers to incentive programs may itself be an effective strategy in prompting the dissemination of CM interventions.
Contingency management in cocaine abusers: a dose-effect comparison of goods-based versus cash-based incentives. [2022]Goods-based contingency management interventions (e.g., those using vouchers or prizes as incentives) have demonstrated efficacy in reducing cocaine use, but cost has limited dissemination to community clinics. Recent research suggests that development of a cash-based contingency management approach may improve treatment outcomes while reducing operational costs of the intervention. However, the clinical safety of providing cash-based incentives to substance abusers has been a concern. The present 16-week study compared the effects of goods-based versus cash-based incentives worth $0, $25, $50, and $100 on short-term cocaine abstinence in a small sample of cocaine-dependent methadone patients (N = 12). A within-subject design was used; a 9-day washout period separated each of 8 incentive conditions. Higher magnitude ($50 and $100) cash-based incentives (checks) produced greater cocaine abstinence compared with the control ($0) condition, but a magnitude effect was not seen for goods-based incentives (vouchers). A trend was observed for greater rates of abstinence in the cash-based versus goods-based incentives at the $50 and $100 magnitudes. Receipt of $100 checks did not increase subsequent rates of cocaine use above those seen in control conditions. The efficacy and safety data provided in this and other recent studies suggest that use of cash-based incentives deserves consideration for clinical applications of contingency management, but additional confirmation in research using larger samples and more prolonged periods of incentive delivery is needed.
Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. [2022]Methamphetamine use is associated with HIV acquisition and transmission among men who have sex with men (MSM). Contingency management (CM), providing positive reinforcement for drug abstinence and withholding reinforcement when abstinence is not demonstrated, may facilitate reduced methamphetamine use and sexual risk. We compared CM as a stand-alone intervention to a minimal intervention control to assess the feasibility of conducting a larger, more definitive trial of CM; to define the frequency of behavioral outcomes to power such a trial; and, to compute preliminary estimates of CM's effectiveness.
Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. [2019]To examine prize-earning costs of contingency management (CM) incentives in relation to participants' pre-study enrollment drug use status (baseline (BL) positive vs. BL negative) and relate these to previously reported patterns of intervention effectiveness.
Contingency management for the treatment of methamphetamine use disorder: A systematic review. [2021]Methamphetamine use continues to be an important public health problem. Contingency management is among the most effective interventions for reducing methamphetamine use. It has been more than ten years since the last systematic review of contingency management for methamphetamine use disorder. Since then, an additional ten randomized controlled trials and a variety of other studies have been completed. The present systematic review includes 27 studies. Several factors, most notably problem severity, appear to predict treatment outcome. However, the effectiveness of CM has been demonstrated in studies restricted to MSM, studies restricted to implementation in community programs, and in studies of the general population of methamphetamine users conducted in research treatment programs. There appear to be broad benefits of contingency management intervention, including greater drug abstinence, higher utilization of other treatments and medical services, and reductions in risky sexual behavior. Twenty of the twenty-one studies that reported abstinence outcomes showed an effect of contingency management on abstinence, and seven of the nine studies that reported sexual risk behavior outcomes showed an effect of contingency management in reducing risky sexual behavior. Taken together, recent evidence suggests strongly that outpatient programs that offer treatment for methamphetamine use disorder should prioritize adoption and implementation of contingency management intervention.
An autoregressive cross-lagged model unraveling co-occurring stimulant use and HIV: Results from a randomized controlled trial. [2022]Evidence-based interventions are needed to address the use of stimulants such as methamphetamine as a driver of onward HIV transmission and faster clinical HIV progression among sexual minority men. Prior randomized controlled trials with people living with HIV who use substances indicate that financial incentives provided during contingency management (CM) are effective for achieving short-term reductions in stimulant use and HIV viral load. However, the benefits of CM are often not maintained after financial incentives for behavior change end.
Contingency management: an evidence-based component of methamphetamine use disorder treatments. [2019]To review briefly some of the available evidence regarding the utility of contingency management in treating methamphetamine use disorders.
Contingency management: schedule effects. [2013]Contingency management interventions provide reinforcement for abstaining from drugs and withhold reinforcement when drug use is detected. Previous work demonstrates that the reinforcement schedule with which reinforcement is delivered modulates the efficacy of the intervention. This pilot study explores the effects of reinforcement in methamphetamine-dependent individuals. Results suggest that schedules incorporating an increasing magnitude of reinforcement for consecutive abstinences with a reset in reinforcer magnitude for a positive drug test produce superior results.
Contingency management for the treatment of methamphetamine use disorders. [2022]Theory and some preliminary evidence suggest that contingency management may be an effective treatment strategy or adjunct to psychosocial treatment for methamphetamine use disorders. An experimentally rigorous investigation on the topic was provided by a large multisite trial conducted under the auspices of the Clinical Trials Network of the National Institute on Drug Abuse.