The Effect of Chronic Pain on Delay Discounting in Methadone Patients

Status Terminated

Clinical Trial Summary

The epidemic of opioid overdose deaths continues to rise, killing more persons in 2017 than HIV/AIDS at the height of that epidemic. Medication assisted treatment, including methadone and buprenorphine, is the standard of care for the treatment of opioid use disorder (OUD). However, chronic pain can reduce treatment efficacy during medication assisted treatment and is associated with illicit substance relapse, dropout, and subsequent overdose. Mechanisms by which chronic pain may influence the impulsive decision making (e.g., drug relapse) in persons with OUD have not been well characterized. A better understanding is needed of decision-making in this population. Two factors that can influence decisions to use drugs are impulsivity and acute opioid withdrawal. This proposal will test how chronic pain is associated with increases in impulsive decision making in OUD, whether impulsive decision making is greater when undergoing opioid withdrawal, and how catastrophizing may modify the association between withdrawal and impulsive decision making in patients with chronic pain and OUD. An ideal population for this developmental research project are methadone maintained patients, who show high treatment attendance rates and will therefore assure study efficiency and reliable completion.

Clinical Trial Description

This is an outpatient Phase 1 clinical trial investigating the effect of naloxone precipitated withdrawal on delay discounting. Eligible participants will undergo two experimental sessions presented in random order. One session will involve the measurement of delay discounting 30 minutes after double-blind intramuscular (IM) administration of placebo (normal saline) and the other will have the exact same procedures performed after double-blind IM administration of naloxone (0.1 mg). Injections will occur 2 hours after methadone dosing (peak levels). Study sessions will last 2 hours and involve pain and opioid withdrawal measures assessed at baseline and 15 minute intervals after injections. The participant should be back to baseline and free of withdrawal by the end of the study session. Sessions will occur at least 48 hours apart. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04473950
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Terminated
Phase	Phase 1
Start date	January 8, 2020
Completion date	October 6, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Enrolling by invitation	`NCT04527926` - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy	N/A
Completed	`NCT04505540` - Start Treatment and Recovery for Opioid Use Disorder	N/A
Completed	`NCT03065049` - Transforming Recovery Through Exercise and Community	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Suspended	`NCT05001789` - Cognitive Functioning in Opioid Use Disorder	N/A
Active, not recruiting	`NCT04650386` - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients	N/A
Completed	`NCT03715634` - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine	Phase 1
Enrolling by invitation	`NCT04991974` - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine	Phase 2/Phase 3
Completed	`NCT04122755` - Single Ascending Dose Study of ALA-1000	Phase 1
Recruiting	`NCT05028998` - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting	`NCT05049460` - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder	N/A
Recruiting	`NCT04927143` - Encouraging Abstinence Behavior in a Drug Epidemic	Phase 2
Completed	`NCT05047627` - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder	N/A
Active, not recruiting	`NCT04129580` - reSET-O RCT (Randomized Controlled Trial)	N/A
Recruiting	`NCT03923374` - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Suspended	`NCT02687360` - Imaging the Effects of rTMS on Chronic Pain	N/A
Completed	`NCT04056182` - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment	Phase 2
Completed	`NCT03766893` - Medication Maintenance Therapy in Community Pharmacy Settings	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.