Study Summary
This trial will test whether offering people with substance abuse disorders incentive payments for healthy behaviors helps them combat their addiction.
Eligible Conditions
- Opioid Use Disorder
- Substance Abuse
- Cocaine Use
- Methamphetamine Addiction
- Methamphetamine Abuse
- Cocaine Use Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 12 weeks
12 weeks
Abstinence from Opioid and/or Cocaine Use
Psychotherapy Completion
Week 12
Negative Saliva Analysis Frequency
Negative Urinalysis Frequency
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
7 Treatment Groups
Control
1 of 7
De-Escalating Low
1 of 7
De-Escalating High
1 of 7
Constant Low
1 of 7
Escalating Low
1 of 7
Escalating High
1 of 7
Constant High
1 of 7
Active Control
Experimental Treatment
600 Total Participants · 7 Treatment Groups
Primary Treatment: App-Based Contingency Management · No Placebo Group · Phase 2
De-Escalating Low
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceDe-Escalating High
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceConstant Low
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceEscalating Low
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceEscalating High
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceConstant High
Device
Experimental Group · 1 Intervention: App-Based Contingency Management · Intervention Types: DeviceControl
Behavioral
ActiveComparator Group · 1 Intervention: Sham Control · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Who is running the clinical trial?
University of ChicagoOTHER
948 Previous Clinical Trials
759,396 Total Patients Enrolled
Rogers Behavioral HealthOTHER
1 Previous Clinical Trials
600 Total Patients Enrolled
Aurora Health CareLead Sponsor
39 Previous Clinical Trials
15,000 Total Patients Enrolled
University of California, Santa CruzOTHER
4 Previous Clinical Trials
1,521 Total Patients Enrolled
Mindy Waite, PhDPrincipal InvestigatorAdvocate Aurora Health
2 Previous Clinical Trials
600 Total Patients Enrolled
Michael Fendrich, PhDPrincipal InvestigatorAdvocate Health Care
4 Previous Clinical Trials
711 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You may benefit from contingency management if you meet at least one of the following criteria:
You have used illegal drugs such as opioids, cocaine, and methamphetamine within the past 3 weeks.
Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Aurora Behavioral Health Services | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Petry, Nancy M., Sheila M. Alessi, Jacqueline Marx, Mark Austin, and Michelle Tardif. 2005. “Vouchers Versus Prizes: Contingency Management Treatment of Substance Abusers in Community Settings.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.73.6.1005.
- Petry, Nancy M., Danielle Barry, Sheila M. Alessi, Bruce J. Rounsaville, and Kathleen M. Carroll. 2012. “A Randomized Trial Adapting Contingency Management Targets Based on Initial Abstinence Status of Cocaine-dependent Patients.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0026883.
- Petry, Nancy M., and Bonnie Martin. 2002. “Low-cost Contingency Management for Treating Cocaine- and Opioid-abusing Methadone Patients.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.70.2.398.
- Prendergast, Michael L., Deborah Podus, Eunice Chang, and Darren Urada. 2002. “The Effectiveness of Drug Abuse Treatment: A Meta-analysis of Comparison Group Studies”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/s0376-8716(02)00014-5.
- Schottenfeld, Richard S., Marek C. Chawarski, Juliana R. Pakes, Michael V. Pantalon, Kathleen M. Carroll, and Thomas R. Kosten. 2005. “Methadone Versus Buprenorphine with Contingency Management or Performance Feedback for Cocaine and Opioid Dependence”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.162.2.340.
- Dutra, Lissa, Ph.D., Georgia Stathopoulou M.A., Shawnee L. Basden M.A., Teresa M. Leyro B.A., Mark B. Powers Ph.D., and Michael W. Otto Ph.D.. 2008. “A Meta-analytic Review of Psychosocial Interventions for Substance Use Disorders”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2007.06111851.
- Romanowich, Paul, and R. J. Lamb. 2015. “The Effects of Fixed Versus Escalating Reinforcement Schedules on Smoking Abstinence”. Journal of Applied Behavior Analysis. Wiley. doi:10.1002/jaba.185.
- Lamb, R. J., Kimberly C. Kirby, Andrew R. Morral, Greg Galbicka, and Martin Y. Iguchi. 2010. “Shaping Smoking Cessation in Hard-to-treat Smokers.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0018323.
- Benishek, Lois A., Karen L. Dugosh, Kim C. Kirby, Jason Matejkowski, Nicolle T. Clements, Brittany L. Seymour, and David S. Festinger. 2014. “Prize-based Contingency Management for the Treatment of Substance Abusers: A Meta-analysis”. Addiction. Wiley. doi:10.1111/add.12589.
- Rash, Carla J., and Nancy M. Petry. 2015. “Contingency Management Treatments Are Equally Efficacious for Both Sexes in Intensive Outpatient Settings.”. Experimental and Clinical Psychopharmacology. American Psychological Association (APA). doi:10.1037/pha0000035.
- Roll, John M, and Stephen T Higgins. 2000. “A Within-subject Comparison of Three Different Schedules of Reinforcement of Drug Abstinence Using Cigarette Smoking as an Exemplar”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/s0376-8716(99)00073-3.
- Roll, John M., Stephen T. Higgins, and Gary J. Badger. 1996. “An Experimental Comparison of Three Different Schedules of Reinforcement of Drug Abstinence Using Cigarette Smoking as an Exemplar”. Journal of Applied Behavior Analysis. Wiley. doi:10.1901/jaba.1996.29-495.
- Romanowich, Paul, and R. J. Lamb. 2010. “Effects of Escalating and Descending Schedules of Incentives on Cigarette Smoking in Smokers Without Plans to Quit”. Journal of Applied Behavior Analysis. Wiley. doi:10.1901/jaba.2010.43-357.
- Higgins, Stephen T., Yukiko Washio, Alexa A. Lopez, Sarah H. Heil, Laura J. Solomon, Mary Ellen Lynch, Jennifer D. Hanson, et al.. 2014. “Examining Two Different Schedules of Financial Incentives for Smoking Cessation Among Pregnant Women”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2014.03.024.
- Hutchinson, Melissa L., Margaret S. Chisolm, Michelle Tuten, Jeannie-Marie S. Leoutsakos, and Hendrée E. Jones. 2012. “The Efficacy of Escalating and Fixed Contingency Management Reinforcement on Illicit Drug Use in Opioid-dependent Pregnant Women”. Addictive Disorders & Their Treatment. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/adt.0b013e318264cf6d.
- Petry, Nancy M., Sheila M. Alessi, Danielle Barry, and Kathleen M. Carroll. 2015. “Standard Magnitude Prize Reinforcers Can Be as Efficacious as Larger Magnitude Reinforcers in Cocaine-dependent Methadone Patients.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0037888.
- Packer, Robert R., Donelle N. Howell, Sterling McPherson, and John M. Roll. 2012. “Investigating Reinforcer Magnitude and Reinforcer Delay: A Contingency Management Analog Study.”. Experimental and Clinical Psychopharmacology. American Psychological Association (APA). doi:10.1037/a0027802.
- Davis, Danielle R., Allison N. Kurti, Joan M. Skelly, Ryan Redner, Thomas J. White, and Stephen T. Higgins. 2016. “A Review of the Literature on Contingency Management in the Treatment of Substance Use Disorders, 2009–2014”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2016.08.008.
- Kirby, Kimberly C., Carolyn M. Carpenedo, Karen L. Dugosh, Beth J. Rosenwasser, Lois A. Benishek, Alicia Janik, Rachel Keashen, Elena Bresani, and Kenneth Silverman. 2013. “Randomized Clinical Trial Examining Duration of Voucher-based Reinforcement Therapy for Cocaine Abstinence”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2013.04.015.
- Ling, Walter, Maureen Hillhouse, Alfonso Ang, Jessica Jenkins, and Jacqueline Fahey. 2013. “Comparison of Behavioral Treatment Conditions in Buprenorphine Maintenance”. Addiction. Wiley. doi:10.1111/add.12266.
- Petry, Nancy M., Jeremiah Weinstock, Sheila M. Alessi, Marilyn W. Lewis, and Kevin Dieckhaus. 2010. “Group-based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0016778.
- Lussier, Jennifer Plebani, Sarah H. Heil, Joan A. Mongeon, Gary J. Badger, and Stephen T. Higgins. 2006. “A Meta-analysis of Voucher-based Reinforcement Therapy for Substance Use Disorders”. Addiction. Wiley. doi:10.1111/j.1360-0443.2006.01311.x.
- Swensen, I.D. (2015). Substance-abuse treatment and mortality. Journal of Public Economics 122, 13-30.
- Roll, John M., Huber, A., Sodano, R., Chudzynski, J.E., Moynier, E., Shoptaw, S. (2006). A Comparison of Five Reinforcement Schedules for Use in Contingency Management-Based Treatment of Methamphetamine Abuse. Psychological Record, 56(1), 67.
- Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. doi: 10.1111/j.1360-0443.2006.01311.x.
- Petry NM, Alessi SM, Marx J, Austin M, Tardif M. Vouchers versus prizes: contingency management treatment of substance abusers in community settings. J Consult Clin Psychol. 2005 Dec;73(6):1005-14. doi: 10.1037/0022-006X.73.6.1005.
- Schottenfeld RS, Chawarski MC, Pakes JR, Pantalon MV, Carroll KM, Kosten TR. Methadone versus buprenorphine with contingency management or performance feedback for cocaine and opioid dependence. Am J Psychiatry. 2005 Feb;162(2):340-9. doi: 10.1176/appi.ajp.162.2.340.
- Davis DR, Kurti AN, Skelly JM, Redner R, White TJ, Higgins ST. A review of the literature on contingency management in the treatment of substance use disorders, 2009-2014. Prev Med. 2016 Nov;92:36-46. doi: 10.1016/j.ypmed.2016.08.008. Epub 2016 Aug 8.
- Roll JM, Higgins ST. A within-subject comparison of three different schedules of reinforcement of drug abstinence using cigarette smoking as an exemplar. Drug Alcohol Depend. 2000 Feb 1;58(1-2):103-9. doi: 10.1016/s0376-8716(99)00073-3.
- Hutchinson ML, Chisolm MS, Tuten M, Leoutsakos JM, Jones HE. The efficacy of escalating and fixed contingency management reinforcement on illicit drug use in opioid-dependent pregnant women. Addict Disord Their Treat. 2012 Sep;11(3):150-153. doi: 10.1097/ADT.0b013e318264cf6d.
- Prendergast ML, Podus D, Chang E, Urada D. The effectiveness of drug abuse treatment: a meta-analysis of comparison group studies. Drug Alcohol Depend. 2002 Jun 1;67(1):53-72. doi: 10.1016/s0376-8716(02)00014-5. Erratum In: Drug Alcohol Depend. 2006 Sep 1;84(1):133.
- Petry NM, Martin B. Low-cost contingency management for treating cocaine- and opioid-abusing methadone patients. J Consult Clin Psychol. 2002 Apr;70(2):398-405. doi: 10.1037//0022-006x.70.2.398.
- Roll JM, Higgins ST, Badger GJ. An experimental comparison of three different schedules of reinforcement of drug abstinence using cigarette smoking as an exemplar. J Appl Behav Anal. 1996 Winter;29(4):495-504; quiz 504-5. doi: 10.1901/jaba.1996.29-495.
- 2021. "Encouraging Abstinence Behavior in a Drug Epidemic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927143.
Frequently Asked Questions
What is the sample size of this medical trial?
"Assertion is accurate. Clinicaltrials.gov provides evidence that the trial, which was initially posted on September 15th 2021, is actively recruiting 600 patients from 3 distinct locations." - Anonymous Online Contributor
Unverified Answer
Is App-Based Contingency Management a safe and effective treatment for patients?
"Power's team has assigned App-Based Contingency Management a score of 2 on their safety scale due to the lack of data indicating efficacy, although clinical evidence does demonstrate its relative security." - Anonymous Online Contributor
Unverified Answer
Are there still opportunities for participants to join this clinical experiment?
"The details published on clinicaltrials.gov confirm that enrollment is currently open for this medical trial, which was first advertised in September 2021 and last updated in November 2022." - Anonymous Online Contributor
Unverified Answer