Opioid CravingNCT05109429
Developing a Clinical Outcome Assessment for Opioid Craving
A study testing Neutral Cue-induced Craving, Visual Opioid Cue-induced Craving and Visual and Tactile Opioid Cue-induced Craving in people with Opioid Craving and Opioid Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Craving, Opioid Use Disorder, Measure Development
- What is being tested?
- Neutral Cue-induced Craving, Visual Opioid Cue-induced Craving and Visual and Tactile Opioid Cue-induced Craving
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
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.
Read the 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
- Being tested
- Neutral Cue-induced Craving, Visual Opioid Cue-induced Craving, Visual and Tactile Opioid Cue-induced Craving
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral Cue-induced CravingBehavioural
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 CravingBehavioural
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 CravingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Craving | Experimental | Each participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion. Receives: Behavioral: Neutral Cue-induced Craving; Behavioral: Visual Opioid Cue-induced Craving; Behavioral: Visual and Tactile Opioid Cue-induced Craving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Average measures of heart rate and galvanic skin response 10 minutes prior to cue-exposure will be subtracted from average measures of heart rate and galvanic skin response for the 10 minutes beginning with cue-exposure to calculate a change from baseline measure of both physiological measures. Greater changes will be indicative of a greater conditioned response. (1) Logistic mixed effects models will evaluate the association between change from baseline physiological measures and whether an individual described a given craving domain across craving condition (domain present, domain absent) and stakeholder group . (2) Linear mixed effects models will evaluate the association between change from baseline heart rate and galvanic skin response and scores on existing craving question single item scores (range: 0-100 and 0-9) across craving condition and stakeholder group. Greater scores on single item craving questions are associated with greater craving.
Measured: Sessions 1, 2, and 3 during and immediately after the cue-induced craving assessment (approximately 1 hour into session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start3 Mar 2022
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid CravingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants will experience all three cue-induced craving tasks (no, low, and high) in a random order (6 possible orders)
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Cecilia L Bergeria, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109429
- Sponsor's protocol ID
- IRB00302133
- Other IDs
- R21DA054952
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Clinical Outcome Assessment for Opioid Craving
- ClinicalTrials.gov ID
- NCT05109429
- Acronym / sponsor ID
- IRB00302133
- Conditions
- Opioid Craving, Opioid Use Disorder, Measure Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will experience all three cue-induced craving tasks (no, low, and high) in a random order (6 possible orders)
| Arm | Type | Receives |
|---|---|---|
| No Craving | Experimental | Behavioral: Neutral Cue-induced Craving, Behavioral: Visual Opioid Cue-induced Craving, Behavioral: Visual and Tactile Opioid Cue-induced CravingEach participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral Cue-induced CravingFor 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. | Behavioural | No Craving |
| Visual Opioid Cue-induced CravingFor 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). | Behavioural | No Craving |
| Visual and Tactile Opioid Cue-induced CravingFor 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. | Behavioural | No Craving |
Primary outcome
Change in Craving Domains
Time frame: Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)
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.
Change in Acceptability of Craving Assessments
Time frame: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
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.
Change in Deficits in Craving Assessments
Time frame: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
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.
1 secondary outcome
Change in Predictive utility of craving assessment items
Time frame: Sessions 1, 2, and 3 during and immediately after the cue-induced craving assessment (approximately 1 hour into session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia L Bergeria, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral Cue-induced Craving, Visual Opioid Cue-induced Craving and Visual and Tactile Opioid Cue-induced Craving in people with Opioid Craving and Opioid Use Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Craving Domains (time frame: Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.