Developing a Clinical Outcome Assessment for Opioid Craving

NCT ID: NCT05109429

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2026-09-30

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.

Detailed Description

There is no universally accepted and validated assessment for opioid craving. Craving is a symptom among individuals with opioid use disorder which can contribute to instances of relapse. More research is needed to develop a valid opioid craving assessment which captures all relevant opioid craving dimensions. Developing a valid, FDA-qualified assessment would support the creation of novel interventions to treat opioid craving and facilitate FDA labeling of a treatment for mitigating opioid craving. To establish content validity, the FDA requires (1) qualitative feedback from stakeholder populations about what should be included in an assessment of opioid craving, and (2) standardized interviews which evaluate participant's acceptability and comprehension of existing assessments of opioid craving. The investigators propose collecting qualitative data in a rigorous laboratory model of cue-induced opioid craving to establish content validity for a craving assessment. Participants (n = 81) will be individuals who are in treatment for opioid use disorder. Participants will attend three outpatient laboratory sessions where the participants will be separately exposed to (1) visual and tactile neutral cues, (2) visual opioid cues, and (3) visual and tactile opioid cues; corresponding to "no", "low", and "high" levels of cue-induced craving. Following cue exposure, participants will be asked to describe in participants' own words the thoughts, moods, and symptoms the participants experience during and after the cue-induced craving task. Next, participants will be asked to complete a brief symptom checklist and rate participants' level of craving for opioids on 9 existing craving questions. Participants will also be asked to provide feedback on existing craving assessments in a standardized interview. Ultimately, these data will identify craving domains experienced across relevant stakeholder populations during both low and high craving bouts.

Conditions

Opioid Craving; Opioid Use Disorder; Measure Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No Craving

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

Group Type: EXPERIMENTAL

Neutral Cue-induced Craving

Intervention Type: 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.

Visual Opioid Cue-induced Craving

Intervention Type: 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).

Visual and Tactile Opioid Cue-induced Craving

Intervention Type: 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.

Interventions

Neutral 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.

Intervention Type: BEHAVIORAL

Visual 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).

Intervention Type: BEHAVIORAL

Visual 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia L Bergeria, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cecilia L Bergeria, PhD

Role: CONTACT

cberge21@jhmi.edu

410-550-1979

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

Role: CONTACT

kdunn9@jhmi.edu

410-550-2254

Facility Contacts

Cecilia Bergeria, Ph.D.

Role: primary

cberge21@jhmi.edu

410-550-1979

Other Identifiers

R21DA054952

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00302133

Identifier Type: -

Identifier Source: org_study_id