Back to resultsAbility of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
Primary Purpose
Opioid-Related Disorders, Heroin Dependence, Substance-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
aprepitant
Pseudo-placebo - buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Heroin abuse, Opioids, Opiates, Substance abuse, Addiction
Eligibility Criteria
Inclusion Criteria:
- Age 18 - 50
- Current opiate use, without dependence
Exclusion Criteria:
- 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.
Sites / Locations
- Karolinska University Hospital, Huddinge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Aprepitant
Placebo
Outcomes
Primary Outcome Measures
The primary outcome will be self-reported pleasurable opiate effect.
Secondary Outcome Measures
The secondary outcome will be physiological opiate responses.
Full Information
NCT ID
NCT00726960
First Posted
July 30, 2008
Last Updated
July 30, 2008
Sponsor
Karolinska University Hospital
Collaborators
Ministry of Health and Social Affairs, Sweden, County of Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT00726960
Brief Title
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
Official Title
Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
Collaborators
Ministry of Health and Social Affairs, Sweden, County of Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Heroin Dependence, Substance-Related Disorders
Keywords
Heroin abuse, Opioids, Opiates, Substance abuse, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Aprepitant
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Oral, 125 mg once daily for one week
Intervention Type
Drug
Intervention Name(s)
Pseudo-placebo - buprenorphine
Other Intervention Name(s)
Subutex
Intervention Description
Randomized to receive either 8 mg sublingual tablets or 0.4 mg sublingual tablets
Primary Outcome Measure Information:
Title
The primary outcome will be self-reported pleasurable opiate effect.
Time Frame
One week
Secondary Outcome Measure Information:
Title
The secondary outcome will be physiological opiate responses.
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 - 50
Current opiate use, without dependence
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Heilig, MD, PhD
Organizational Affiliation
Karolinska Universitetssjukhuset
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan Kakko, MD
Organizational Affiliation
Karolinska Universitetssjukhuset
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
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