The Effect of Chronic Pain on Delay Discounting in Methadone Patients
TerminatedPhase 1NCT04473950
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effect of Chronic Pain on Delay Discounting in Methadone Patients
- Conditions
- Interventions
- Drug: Naloxone Hydrochloride
- Drug: Placebo
- Sponsor
- University of California, San Francisco
- Collaborators
- Johns Hopkins University; National Institute on Drug Abuse (NIDA)
- Start date
- 2020-01-08
- Primary completion
- 2022-10-06
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male and female adults aged 18-65 * Stable methadone dose (at least 21 days) verified by contacting participant's opioid treatment program * Understand and speak English * Urine toxicology screen negative for drugs of abuse and positive for methadone * Participants must be without signs of intoxication as evidenced by ability to receive full dose of methadone prior to research activities. * Presence of chronic pain (\>3 months) for the Pain group and absence of pain for the No Pain group. Exclusion Criteria: * Unstable psychiatric illness as assessed by the Mini International Neuropsychiatric Interview (e.g. active suicidal ideation, psychosis) * Unstable medical illness as assessed by the study's independent medical monitor (e.g. uncontrolled hypertension, recent myocardial infarction, recent stroke, unstable angina) that may be affected by precipitated withdrawal * Prescription opioid use besides methadone * Acute pain process unrelated to chronic pain * Women who are pregnant or lactating * Known allergy to naloxone
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04473950