Opioid Use Disorder (OUD)NCT07208266
Contingency Management for Opioid Use Disorder in Inpatients at Assiut University Hospital
A study testing contingency management in people with Opioid Use Disorder (OUD), run by Assiut University.
Trial summary
A scientific study to design and implement a contingency management (CM) program, and to evaluate its effectiveness in promoting abstinence and treatment adherence among individuals with opioid use disorder, as well as to explore its potential for broader implementation in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Opioid Use Disorder (OUD)
- What is being tested?
- contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older
- Have a diagnosis of a substance use disorder (SUD) according to DSM-5 criteria
- Be able to understand and provide informed consent
- Be willing to comply with study procedures, including regular drug screening and attendance tracking
- Must be able to swallow tablets
Who cannot join
- Have a severe cognitive impairment or active psychosis that interferes with participation
- Currently experiencing a medical condition that would make participation unsafe
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alaa El-Din Mohamed Darwish, Prof contact
About this study
Official title: Contingency Management as a Behavioral Intervention for Patients With Opioid Use Disorder : Implementation and Efficacy in the Inpatient Setting at Assiut University Hospital.
A scientific study to design and implement a contingency management (CM) program, and to evaluate its effectiveness in promoting abstinence and treatment adherence among individuals with opioid use disorder, as well as to explore its potential for broader implementation in clinical settings.
Read the detailed description
Addiction and drug use can have negative consequences on the health, economy, productivity, and social aspects of communities. Addictive disorders are of high prevalence and often associated with other psychiatric and somatic diseases. Severe cases, often complicated by multiple dependencies of substances and advanced stages of the disease can require the involvement of a variety of caregivers, who are requested to sufficiently cooperate and interact to guarantee an optimal outcome of treatment. Tolerance and withdrawal are the two hallmark criteria of physiological addiction, and, arguably, may also be considered as aspects of a more general concept of preoccupation (or as features that contribute to preoccupation). Tolerance refers to the need to engage in the behavior at a relatively greater level than in the past to achieve previous levels of appetitive effects. As tolerance increases, one likely spends more time locating and engaging in an addiction. Thus, tolerance may indicate increasing preoccupation. Withdrawal refers to physiological or acquired discomfort experienced upon abrupt termination of an addictive behavior. If withdrawal symptoms exist, and worsen, one is likely to be spending more and more time recovering from the after-effects of the addiction, and focused in thought and action on how to cope (e.g., by using again). That is, one is more preoccupied with the addiction when one is spending more time locating, engaging, and recovering from that behavior, and this may reflect processes of tolerance and withdrawal. Historically, addiction treatment systems and research have been organized to provide and improve the outcomes of acute episodes of care. The conceptual model has been that an addicted person seeks treatment, completes an assessment, receives treatment, and is discharged, all in a period of weeks or months. This orientation stands at variance with clinical experience and studies conducted over several decades, which confirm that, although some individuals can be successfully treated within an acute care framework, more than half the patients entering publicly funded addiction programs require multiple episodes of treatment over several years to achieve and sustain recovery. The progress of many patients is marked by cycles of recovery, relapse, and repeated treatments, often spanning many years before eventuating in stable recovery, permanent disability, or death.
Contingency management (CM) is a promising intervention for treating drug dependence. CM treatments rearrange the environment to detect drug use readily and to promote participation in activities that are inconsistent with drug use. These treatments encourage participation upon objective evidence of drug abstinence or engagement in non-drug-related activities. Contingency management (CM) is a behavioral intervention where reinforcement is provided when biologically confirmed drug abstinence is demonstrated, typically in the form of a urine test. Unlike some substance use disorders (SUDs) where there are pharmacological treatments available, all empirically supported treatments for stimulant use disorder are behavioral, and contingency management (CM) has the strongest support. CM, or the provision of reinforcement to encourage abstinence from substances or other behaviors, has strong empirical support, established over decades of research, for the treatment of SUDs, including stimulant, nicotine, alcohol, and opioid use disorders. Although CM is efficacious, it is rarely implemented in practice. A primary obstacle is cost.
- Conditions
- Opioid Use Disorder (OUD)
- Being tested
- contingency management
- Keywords
- Opioid Use Disorder, Contingency Management, Assiut University Hospital
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contingency managementBehavioural
Participants with opioid use disorder admitted to the inpatient addiction management unit will receive a contingency management (CM) program as a behavioral intervention. The program consists of providing positive reinforcement (small rewards or incentives) contingent upon objective evidence of desired behaviors, primarily drug abstinence verified by urine toxicology screening. The intervention will be delivered throughout the inpatient stay (approximately two weeks). Participants' adherence and abstinence will be monitored, and rewards will be adjusted based on performance.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management Intervention | Experimental | Not described Receives: Behavioral: contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Risk Assessment: Assessed using the Advance Warning of Relapse (AWARE) Questionnaire administered at program entry and exit. Changes in AWARE scores will indicate changes in relapse risk and warning signs.
Measured: From baseline (admission) until discharge (~2 weeks), and at 3 months post-discharge
Proportion of opioid-negative urine drug screens during inpatient stay and at 3-month follow-up
Measured: From baseline (admission) until discharge (~2 weeks), and at 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaei Raouf Zaki Samuel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208266
- Sponsor's protocol ID
- NeuroPsych-CM-2025
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rawson RA, Erath TG, Chalk M, Clark HW, McDaid C, Wattenberg SA, Roll JM, McDonell MG, Parent S, Freese TE. Contingency Management for Stimulant Use Disorder: Progress, Challenges, and Recommendations. J Ambul Care Manage. 2023 Apr-Jun 01;46(2):152-159. doi: 10.1097/JAC.0000000000000450. Epub 2023 Feb 3.
PubMed 36745163Kwon M, Yang S, Park K, Kim DJ. Factors that affect substance users' suicidal behavior: a view from the Addiction Severity Index in Korea. Ann Gen Psychiatry. 2013 Nov 12;12(1):35. doi: 10.1186/1744-859X-12-35.
PubMed 24220264Petry NM, Barry D, Alessi SM, Rounsaville BJ, Carroll KM. A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. J Consult Clin Psychol. 2012 Apr;80(2):276-85. doi: 10.1037/a0026883. Epub 2012 Jan 9.
PubMed 22229758Coughlin LN, Zhang L, Frost MC, Khazanov G, McKay JR, DePhilippis D, Lin LA. Contingency management for substance use disorders in the U.S. Veterans Health Administration: 2018-2022. J Subst Use Addict Treat. 2024 Aug;163:209400. doi: 10.1016/j.josat.2024.209400. Epub 2024 May 11.
PubMed 38735480McDonell MG, Skalisky J, Burduli E, Foote A Sr, Granbois A, Smoker K, Hirchak K, Herron J, Ries RK, Echo-Hawk A, Barbosa-Leiker C, Buchwald D, Roll J, McPherson SM. The rewarding recovery study: a randomized controlled trial of incentives for alcohol and drug abstinence with a rural American Indian community. Addiction. 2021 Jun;116(6):1569-1579. doi: 10.1111/add.15349. Epub 2021 Jan 14.
PubMed 33220122Petry NM, Tedford J, Austin M, Nich C, Carroll KM, Rounsaville BJ. Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? Addiction. 2004 Mar;99(3):349-60. doi: 10.1111/j.1360-0443.2003.00642.x.
PubMed 14982548Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.
PubMed 18292710Sussman S, Sussman AN. Considering the definition of addiction. Int J Environ Res Public Health. 2011 Oct;8(10):4025-38. doi: 10.3390/ijerph8104025. Epub 2011 Oct 20.
PubMed 22073026Hofer D, Wenger F, Kohler M, Badertscher M. [Addiction in psychiatric ambulatory service]. Ther Umsch. 2014 Oct;71(10):609-16. doi: 10.1024/0040-5930/a000600. German.
PubMed 25257115GBD 2016 Alcohol and Drug Use Collaborators. The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Psychiatry. 2018 Dec;5(12):987-1012. doi: 10.1016/S2215-0366(18)30337-7. Epub 2018 Nov 1.
PubMed 30392731
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management as a Behavioral Intervention for Patients With Opioid Use Disorder : Implementation and Efficacy in the Inpatient Setting at Assiut University Hospital.
- ClinicalTrials.gov ID
- NCT07208266
- Acronym / sponsor ID
- NeuroPsych-CM-2025
- Conditions
- Opioid Use Disorder (OUD)
- Keywords
- Opioid Use Disorder, Contingency Management, Assiut University Hospital
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A scientific study to design and implement a contingency management (CM) program, and to evaluate its effectiveness in promoting abstinence and treatment adherence among individuals with opioid use disorder, as well as to explore its potential for broader implementation in clinical settings.
Detailed description
Addiction and drug use can have negative consequences on the health, economy, productivity, and social aspects of communities. Addictive disorders are of high prevalence and often associated with other psychiatric and somatic diseases. Severe cases, often complicated by multiple dependencies of substances and advanced stages of the disease can require the involvement of a variety of caregivers, who are requested to sufficiently cooperate and interact to guarantee an optimal outcome of treatment. Tolerance and withdrawal are the two hallmark criteria of physiological addiction, and, arguably, may also be considered as aspects of a more general concept of preoccupation (or as features that contribute to preoccupation). Tolerance refers to the need to engage in the behavior at a relatively greater level than in the past to achieve previous levels of appetitive effects. As tolerance increases, one likely spends more time locating and engaging in an addiction. Thus, tolerance may indicate increasing preoccupation. Withdrawal refers to physiological or acquired discomfort experienced upon abrupt termination of an addictive behavior. If withdrawal symptoms exist, and worsen, one is likely to be spending more and more time recovering from the after-effects of the addiction, and focused in thought and action on how to cope (e.g., by using again). That is, one is more preoccupied with the addiction when one is spending more time locating, engaging, and recovering from that behavior, and this may reflect processes of tolerance and withdrawal. Historically, addiction treatment systems and research have been organized to provide and improve the outcomes of acute episodes of care. The conceptual model has been that an addicted person seeks treatment, completes an assessment, receives treatment, and is discharged, all in a period of weeks or months. This orientation stands at variance with clinical experience and studies conducted over several decades, which confirm that, although some individuals can be successfully treated within an acute care framework, more than half the patients entering publicly funded addiction programs require multiple episodes of treatment over several years to achieve and sustain recovery. The progress of many patients is marked by cycles of recovery, relapse, and repeated treatments, often spanning many years before eventuating in stable recovery, permanent disability, or death.
Contingency management (CM) is a promising intervention for treating drug dependence. CM treatments rearrange the environment to detect drug use readily and to promote participation in activities that are inconsistent with drug use. These treatments encourage participation upon objective evidence of drug abstinence or engagement in non-drug-related activities. Contingency management (CM) is a behavioral intervention where reinforcement is provided when biologically confirmed drug abstinence is demonstrated, typically in the form of a urine test. Unlike some substance use disorders (SUDs) where there are pharmacological treatments available, all empirically supported treatments for stimulant use disorder are behavioral, and contingency management (CM) has the strongest support. CM, or the provision of reinforcement to encourage abstinence from substances or other behaviors, has strong empirical support, established over decades of research, for the treatment of SUDs, including stimulant, nicotine, alcohol, and opioid use disorders. Although CM is efficacious, it is rarely implemented in practice. A primary obstacle is cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency Management Intervention | Experimental | Behavioral: contingency management |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 years of age or older
- Have a diagnosis of a substance use disorder (SUD) according to DSM-5 criteria
- Be able to understand and provide informed consent
- Be willing to comply with study procedures, including regular drug screening and attendance tracking
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Have a severe cognitive impairment or active psychosis that interferes with participation
- Currently experiencing a medical condition that would make participation unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contingency managementParticipants with opioid use disorder admitted to the inpatient addiction management unit will receive a contingency management (CM) program as a behavioral intervention. The program consists of providing positive reinforcement (small rewards or incentives) contingent upon objective evidence of desired behaviors, primarily drug abstinence verified by urine toxicology screening. The intervention will be delivered throughout the inpatient stay (approximately two weeks). Participants' adherence and abstinence will be monitored, and rewards will be adjusted based on performance. | Behavioural | Contingency Management Intervention |
Primary outcome
Relapse Risk Assessment: Assessed using the Advance Warning of Relapse (AWARE) Questionnaire administered at program entry and exit. Changes in AWARE scores will indicate changes in relapse risk and warning signs.
Time frame: From baseline (admission) until discharge (~2 weeks), and at 3 months post-discharge
Proportion of opioid-negative urine drug screens during inpatient stay and at 3-month follow-up
Time frame: From baseline (admission) until discharge (~2 weeks), and at 3 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Results publication: PubMed 36745163Rawson RA, Erath TG, Chalk M, Clark HW, McDaid C, Wattenberg SA, Roll JM, McDonell MG, Parent S, Freese TE. Contingency Management for Stimulant Use Disorder: Progress, Challenges, and Recommendations. J Ambul Care Manage. 2023 Apr-Jun 01;46(2):152-159. doi: 10.1097/JAC.0000000000000450. Epub 2023 Feb 3.
- Results publication: PubMed 24220264Kwon M, Yang S, Park K, Kim DJ. Factors that affect substance users' suicidal behavior: a view from the Addiction Severity Index in Korea. Ann Gen Psychiatry. 2013 Nov 12;12(1):35. doi: 10.1186/1744-859X-12-35.
- Results publication: PubMed 22229758Petry NM, Barry D, Alessi SM, Rounsaville BJ, Carroll KM. A randomized trial adapting contingency management targets based on initial abstinence status of cocaine-dependent patients. J Consult Clin Psychol. 2012 Apr;80(2):276-85. doi: 10.1037/a0026883. Epub 2012 Jan 9.
- Results publication: PubMed 38735480Coughlin LN, Zhang L, Frost MC, Khazanov G, McKay JR, DePhilippis D, Lin LA. Contingency management for substance use disorders in the U.S. Veterans Health Administration: 2018-2022. J Subst Use Addict Treat. 2024 Aug;163:209400. doi: 10.1016/j.josat.2024.209400. Epub 2024 May 11.
- Results publication: PubMed 33220122McDonell MG, Skalisky J, Burduli E, Foote A Sr, Granbois A, Smoker K, Hirchak K, Herron J, Ries RK, Echo-Hawk A, Barbosa-Leiker C, Buchwald D, Roll J, McPherson SM. The rewarding recovery study: a randomized controlled trial of incentives for alcohol and drug abstinence with a rural American Indian community. Addiction. 2021 Jun;116(6):1569-1579. doi: 10.1111/add.15349. Epub 2021 Jan 14.
- Results publication: PubMed 14982548Petry NM, Tedford J, Austin M, Nich C, Carroll KM, Rounsaville BJ. Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? Addiction. 2004 Mar;99(3):349-60. doi: 10.1111/j.1360-0443.2003.00642.x.
- Results publication: PubMed 18292710Dennis M, Scott CK. Managing addiction as a chronic condition. Addict Sci Clin Pract. 2007 Dec;4(1):45-55. doi: 10.1151/ascp074145.
- Results publication: PubMed 22073026Sussman S, Sussman AN. Considering the definition of addiction. Int J Environ Res Public Health. 2011 Oct;8(10):4025-38. doi: 10.3390/ijerph8104025. Epub 2011 Oct 20.
- Results publication: PubMed 25257115Hofer D, Wenger F, Kohler M, Badertscher M. [Addiction in psychiatric ambulatory service]. Ther Umsch. 2014 Oct;71(10):609-16. doi: 10.1024/0040-5930/a000600. German.
- Results publication: PubMed 30392731GBD 2016 Alcohol and Drug Use Collaborators. The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Psychiatry. 2018 Dec;5(12):987-1012. doi: 10.1016/S2215-0366(18)30337-7. Epub 2018 Nov 1.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa El-Din Mohamed Darwish, Prof contact
Questions about this trial
What is this clinical trial studying?
A study testing contingency management in people with Opioid Use Disorder (OUD), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ragaei Raouf Zaki, Master's degree (M.Sc.) in (+201095378996, ragaai.17289624@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Risk Assessment: Assessed using the Advance Warning of Relapse (AWARE) Questionnaire administered at program entry and exit. Changes in AWARE scores will indicate changes in relapse risk and warning signs. (time frame: From baseline (admission) until discharge (~2 weeks), and at 3 months post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208266, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.