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NCT04473950 · ClinicalTrials.gov registry record · Phase 1

The Effect of Chronic Pain on Delay Discounting in Methadone Patients

A Phase 1 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 1
Development phase
10
Enrollment target

NCT04473950: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.

NCT04473950 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04473950, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study 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.

Primary Outcome

Delay discounting is the relative preference for smaller sooner over larger later rewards, an aspect of impulsivity. Most individuals would prefer an immediate $100 over $100 delayed by 1 year. However, when faced with the choice between receiving $95 now versus $100 in 1 year, preferences for the delayed reward may increase. By assessing such choices across multiple delays, delay discounting quantifies the devaluation of rewards over time, which allows for an index of overall discounting rate (

Interventions

  • DRUG Placebo
  • DRUG Naloxone Hydrochloride

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-01-08
Est. Completion 2022-10-06
Phase Phase 1

Why NCT04473950 stopped before completion

NCT04473950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04473950 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04473950 about?

NCT04473950 is a clinical study titled "The Effect of Chronic Pain on Delay Discounting in Methadone Patients". 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...

What is the current status of trial NCT04473950?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-01-08. Estimated completion is 2022-10-06.

What interventions are being tested in trial NCT04473950?

The interventions under investigation include: Placebo (DRUG), Naloxone Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT04473950?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04473950's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04473950, the US trial registry maintained by the National Library of Medicine. NCT04473950 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.