Opioid-Related DisordersPhase 1NCT00726960
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
A Phase 1 study testing aprepitant in people with Opioid-Related Disorders and Heroin Dependence, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Opioid-Related Disorders, Heroin Dependence, Substance-Related Disorders
- What is being tested?
- aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 50
- Current opiate use, without dependence
Who cannot join
- Clinical diagnosis of opiate dependence
- Positive urine screen for opiates on day of challenge sessions
- Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
- Any ongoing prescription medication other than oral contraceptives or hormone replacement
- Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.
Read the detailed description
This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.
- Being tested
- aprepitant, Pseudo-placebo - buprenorphine
- Keywords
- Heroin abuse, Opioids, Opiates, Substance abuse, Addiction
- Medical subject headings
- Opioid-Related Disorders, Heroin Dependence, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called Emend
Oral, 125 mg once daily for one week
Pseudo-placebo - buprenorphineDrug
Also called Subutex
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aprepitant Receives: Drug: aprepitant |
| 2 | Placebo comparator | Placebo Receives: Drug: Pseudo-placebo - buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be self-reported pleasurable opiate effect.
Measured: One week
Secondary outcomes (1)
The secondary outcome will be physiological opiate responses.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden, County of Stockholm
- Investigators
- Markus Heilig, MD, PhD, Principal investigator, Karolinska University HospitalJohan Kakko, MD, Study director, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726960
- Sponsor's protocol ID
- Aprepitant 1
- Status last verified
- Jul 2008
- First submitted
- 30 Jul 2008
- Last updated
- 1 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
- ClinicalTrials.gov ID
- NCT00726960
- Acronym / sponsor ID
- Aprepitant 1
- Keywords
- Heroin abuse, Opioids, Opiates, Substance abuse, Addiction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden, County of Stockholm
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 1 Aug 2008 (estimated)
- 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 objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.
Detailed description
This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aprepitantAprepitant |
| 2 | Placebo comparator | Drug: Pseudo-placebo - buprenorphinePlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 - 50
- Current opiate use, without dependence
Key exclusion criteria (5 listed)
- Clinical diagnosis of opiate dependence
- Positive urine screen for opiates on day of challenge sessions
- Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
- Any ongoing prescription medication other than oral contraceptives or hormone replacement
- Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.
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 |
|---|---|---|
| aprepitantAlso: EmendOral, 125 mg once daily for one week | Drug | 1 |
| Pseudo-placebo - buprenorphineAlso: SubutexRandomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets | Drug | 2 |
Primary outcome
The primary outcome will be self-reported pleasurable opiate effect.
Time frame: One week
1 secondary outcome
The secondary outcome will be physiological opiate responses.
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2008.
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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.
Markus Heilig, MD, PhD principal investigator
Karolinska University Hospital
Johan Kakko, MD study director
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aprepitant in people with Opioid-Related Disorders and Heroin Dependence, run by Karolinska University Hospital at 1 site in Sweden.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2008. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The primary outcome will be self-reported pleasurable opiate effect. (time frame: One week). 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 1 Aug 2008.