Developing a Clinical Outcome Assessment for Opioid Craving

Johns Hopkins University

Status

Enrolling

Conditions

Opioid Craving

Opioid Use Disorder

Measure Development

Treatments

Behavioral: Visual Opioid Cue-induced Craving

Behavioral: Neutral Cue-induced Craving

Behavioral: Visual and Tactile Opioid Cue-induced Craving

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05109429

IRB00302133

R21DA054952 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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