Developing a Clinical Outcome Assessment for Opioid Craving

NCT05109429 | Recruiting

• 2 other identifiers: IRB00302133R21DA054952
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Craving; Opioid Use Disorder; Measure Development

Outcome Measures

Primary Outcomes (3)

• Change in Craving Domains

  Immediately following each cue condition, participants will be asked the following open-ended questions: (1) Describe your mood, (2) Describe how you feel, and (3) What symptoms are you experiencing? Responses will be recorded using a digital audio recorder. Qualitative data collected on the symptoms, moods and feelings following cue-induced craving tasks will be transcribed and independently coded for common craving domains based on our published preliminary study by two raters. Raters will also document other potential domains that do not fit into any of the a priori categories. Ad Hoc domains require that both raters agree that a new category should be created. Independently coded responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. The types and frequencies of craving domains will be summarized with descriptive statistics.

  Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)

• Change in Acceptability of Craving Assessments

  Responses to the question "What was this question designed to measure?" will be coded by two independent raters as either "Demonstrates understanding" or "Does not demonstrate understanding". Next, responses to the question "What would you change, if anything, about this measure?", will be transcribed and independently coded by two raters as either "no changes needed" or "changes needed". Responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. If final responses to either question is determined to be either "does not demonstrate understanding" and/or "changes needed", the question will be labeled as unacceptable. For each craving assessment item, the proportion of participants who describe the item as unacceptable will be computed. The proportions of responses designated as "does not demonstrate understanding" and "changes needed" will also be computed.

  Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)

• Change in Deficits in Craving Assessments

  Responses to the question "What was not captured by these questions that you would include in a measure for assessing opioid craving?" will be coded for themes by two independent raters. Independently coded responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. The types and frequencies of recommendations will be summarized with descriptive statistics.

  Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)

Secondary Outcomes (1)

• Change in Predictive utility of craving assessment items

  Sessions 1, 2, and 3 during and immediately after the cue-induced craving assessment (approximately 1 hour into session)

Study Arms (1)

No Craving

EXPERIMENTAL

Each participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion.

Behavioral: Neutral Cue-induced Craving; Behavioral: Visual Opioid Cue-induced Craving; Behavioral: Visual and Tactile Opioid Cue-induced Craving

Interventions

Neutral Cue-induced Craving BEHAVIORAL

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.

No Craving

Visual Opioid Cue-induced Craving BEHAVIORAL

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).

No Craving

Visual and Tactile Opioid Cue-induced Craving BEHAVIORAL

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.

No Craving

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Cecilia L Bergeria, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia L Bergeria, PhD

CONTACT

410-550-1979; cberge21@jhmi.edu

Kelly Dunn, Ph.D., M.B.A.

CONTACT

410-550-2254; kdunn9@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind the participant nor some of the research staff to the study condition. The research staff who will interview the participant will be blinded to what cue condition participant had completed.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will experience all three cue-induced craving tasks (no, low, and high) in a random order (6 possible orders)

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 5, 2021
• Study Start: March 3, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)