- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360371
A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
September 8, 2021 updated by: Johns Hopkins University
Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants completed a 5-day, within-subject, double-blind, placebo-controlled, randomized, human laboratory abuse potential trial.
Healthy individuals were admitted to a residential research unit for 5 consecutive days.
Blood samples were drawn for genome wide analyses using the Global Screening Array on day 1.
Participants were administered an oral dose of the opioid hydromorphone (4mg) on day 2 of the study.
Persons who did not evidence strong agonist effects then proceeded into the randomized period wherein they received 0mg, 2mg, and 8mg of oral hydromorphone on the remaining three study days.
The order of dosing was randomized, with only 1 dose administered per day and all participants receiving 1 exposure to each dose.
Outcomes were standard human abuse potential metrics, including self-reported drug effects and feeling high.
Data were analyzed as a function of the A118SNP on the OPRM1 gene that codes for the mu opioid receptor.
The overall aim was to determine whether signal for abuse potential among persons with no history of opioid misuse was associated with genotype.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University Bayview Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criterion:
- Provide a urine sample that tests negative for opioids, methadone, buprenorphine, oxycodone, amphetamine, cocaine, and benzodiazepines
- Negative ethanol breath test (0.000)
- Aged 21-50
- Deemed medically eligible to take hydromorphone
Exclusion Criterion:
- Answer "yes" to question 1 of the Brief Pain Inventory (89) to assess the presence of chronic pain.
- Current use of opioids or other medications for pain
- Meet DSM-5 criteria for current or lifetime alcohol or drug use disorder (excluding nicotine)
- Self-report any illicit drug use in the past 7 days
- Self-report opioid use >5 days in the past 30
- Evidence of opioid physical dependence at screening or following 1st residential overnight (following confirmed opioid abstinence)
- Allergy to hydromorphone or other opioid agonists
- Experience an adverse event that warrants opioid antagonist treatment following 1st hydromorphone dose.
- If female, not be pregnant or breastfeeding
- Presence of any clinically significant medical (e.g., chronic renal insufficiency, history of myocardial infarction, seizure disorder) and/or psychiatric illness (e.g., schizophrenia, bipolar disorder) that may interfere with study participation.
- BMI >30 (obese category)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo (oral)
Within-subject double-blind, administration of placebo oral capsule.
Order of dose randomized session days 3-5.
|
Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study.
All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order.
Only one dose was administered per day and following randomized all participants received each dose in random order.
Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
|
Experimental: Hydromorphone (oral) 2mg
Within-subject double-blind, administration of hydromorphone via oral capsule.
Order of dose randomized session days 3-5.
|
Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study.
All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order.
Only one dose was administered per day and following randomized all participants received each dose in random order.
Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
|
Experimental: Hydromorphone (oral) 4mg
Hydromorphone oral capsule administered in double-blind manner on Day 2 as first study drug administration.
Hydromorphone 4mg dosing day was set for safety purposes and non-randomized.
|
Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study.
All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order.
Only one dose was administered per day and following randomized all participants received each dose in random order.
Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
|
Experimental: Hydromorphone (oral) 8mg
Within-subject double-blind, administration of hydromorphone via oral capsule.
Order of dose randomized session days 3-5.
|
Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study.
All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order.
Only one dose was administered per day and following randomized all participants received each dose in random order.
Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report Visual Analog Ratings of HIGH
Time Frame: 30 minutes after study drug administration
|
Peak visual analog rating scale values of HIGH (rated on 0-100 scale with higher scores indicating higher feeling of being HIGH) collected at 30 minute intervals post-drug administration for 6 hours.
|
30 minutes after study drug administration
|
Self-report Visual Analog Ratings of DRUG EFFECT
Time Frame: 30 minutes after study drug administration
|
Peak visual analog rating scale values of DRUG EFFECT (rated on 0-100 scale with higher scores indicating higher drug effect) collected at 30 minute intervals post-drug administration for 6 hours.
|
30 minutes after study drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelly E Dunn, Ph.D., MBA, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
January 29, 2015
First Submitted That Met QC Criteria
February 5, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Actual)
October 5, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00047423
- R01DA035246-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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