Clinical trial NCT05109429: Developing a Clinical Outcome Assessment for Opioid Craving
Official title: Developing a Clinical Outcome Assessment for Opioid Craving
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Craving
Opioid Use Disorder
Measure Development
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-11-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will experience all three cue-induced craving tasks (no, low, and high) in a random order (6 possible orders)
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Craving Domains
timeFrame: Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)
measure: Change in Acceptability of Craving Assessments
timeFrame: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
measure: Change in Deficits in Craving Assessments
timeFrame: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
Secondary outcomes:
measure: Change in Predictive utility of craving assessment items
timeFrame: Sessions 1, 2, and 3 during and immediately after the cue-induced craving assessment (approximately 1 hour into session)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cecilia L Bergeria, PhD
role: PRINCIPAL_INVESTIGATOR
References: