RecruitingNot ApplicableNCT05109429

Developing a Clinical Outcome Assessment for Opioid Craving


Sponsor

Johns Hopkins University

Enrollment

81 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to collect information about opioid craving so that the investigators can develop an opioid craving assessment to improve treatments for individuals with opioid use disorder. To collect this information, the investigators are recruiting individuals in treatment for opioid use disorder who will complete cue-induced opioid craving tasks where these individuals will: (1) look at pictures of neutral objects and touch neutral objects (e.g., water bottles or flashlights), (2) look at opioid-related images, and (3) look and touch opioid-related objects. Participants will then complete a one-on-one interview about the thoughts, feelings and physical sensations the participants experienced during the cue-induced craving session. Participants will also complete questionnaires and existing opioid craving assessments. Finally, participants will provide formal feedback about existing opioid craving assessments with cognitive interviews.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • years of age and older
  • Opioid-positive urine sample at admission visit (excluding individuals receiving Naltrexone).
  • Current opioid use disorder per Diagnostic Statistical Manual (DSM)-5
  • Currently in treatment for opioid use disorder

Exclusion Criteria7

  • Being pregnant or breastfeeding, or may become pregnant during the trial
  • History of psychosis or mania or other serious psychiatric disorders assessed by the Mini International Neuropsychiatric Interview
  • Past 30-day suicidal behavior assessed by the Columbia Suicide Severity Rating Scale
  • Have circumstances that would interfere with study participation (e.g., impending jail).
  • Positive for illicit substances except opioids and cannabis
  • Current substance use disorder other than opioid or nicotine
  • Current intoxication

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALNeutral Cue-induced Craving

For the neutral cue condition, the participant will be seated in front of a 16-inch monitor and instructed to sit upright to view 20 pictures of water bottles via E-Prime software (Psychology Software Tools Inc., PA), presented for five seconds each in randomized order. The images will include pictures of a water bottle alone, water being poured from a bottle to a glass, and an individual drinking from a bottle of water. Next, participants will watch as research staff open a bottle of water, pour it into a glass, and place it on a table in front of the participant. Participants will also be asked to look at a water bottle, hold it, sniff it, and take a drink of water.

BEHAVIORALVisual Opioid Cue-induced Craving

For the visual opioid cue-induced craving condition, the participant will again be seated in front of a 16-inch monitor and instructed to sit upright to view 20 pictures of opioid-related imagery, presented for five seconds each in a randomized order. The opioid-related imagery will be customized for heroin or prescription opioids based upon the participant's primary opioid of choice. The images will include pills and white powder, stages of drug taking preparation (e.g., holding spoon over flame, pills being crushed).

BEHAVIORALVisual and Tactile Opioid Cue-induced Craving

For the visual and tactile opioid cue condition, procedures will differ depending on the participants' most preferred route of administration. . Intranasal users will be instructed to watch as research staff opens a wallet, removes a $1 bill, removes a packet of powder mimicking heroin/crushed pills, open the packet, and roll the dollar bill. The participant will then be given the packet and the dollar bill to hold for approximately 30 seconds. Intravenous users will be instructed to watch the research nurse open the packet of fake heroin, pour its contents into a spoon, added a few drops of water to the spoon, hold an open flame from a lighter under the spoon, add cotton to the spoon, and draw the fluid into a syringe.


Locations(1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05109429