Heroin DependencePhase 2NCT00000273
A Laboratory Model for Heroin Abuse Medications - 8
A Phase 2 study testing opiates in people with Heroin Dependence and Opioid-Related Disorders, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration." Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- opiates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 1995to Nov 2005
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM IV criteria for opioid dependence
- No major mood, psychotic, or anxiety disorder
- Physically healthy
- Able to perform study procedures
- 21-45 years of age
- Current use of i.v. heroin in amounts/frequencies
- Not seeking treatment for opioid dependence
Who cannot join
- DSM IV criteria for dependence on drugs other
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation
- Birth, miscarriage or abortion with 6 months
- Recent history of or current significant violent behavior
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- Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study
- Hepatitis with SGOT or SGPT > 3 times normal
- Significant suicide risk
- Current or history of chronic pain
- Sensitivity, allergy, or contraindication to opioids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A Laboratory Model for Heroin Abuse Medications
The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
Read the detailed description
Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.
- Being tested
- opiates
- Keywords
- heroin, opioid disorders, substance related disorders
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opiatesDrug
Also called morphine, fentanyl, buprenorphine, oxycodone
prescription opioids
| Study group | Role | What they receive |
|---|---|---|
| Opiates | Experimental | Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol. Receives: Drug: opiates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount drug self-administered
All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward..
Measured: 90 minutes
Secondary outcomes (1)
Subjective responses
Four questionnaires were used to assess subjective effects
Measured: 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startAug 1995
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Herbert Kleber, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000273
- Sponsor's protocol ID
- #4857/5982R
- Other IDs
- 5P50DA009236-18
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 1999
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Comer SD, Sullivan MA, Whittington RA, Vosburg SK, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology. 2008 Apr;33(5):1179-91. doi: 10.1038/sj.npp.1301479. Epub 2007 Jun 20.
PubMed 17581533
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Model for Heroin Abuse Medications
- ClinicalTrials.gov ID
- NCT00000273
- Acronym / sponsor ID
- #4857/5982R
- Keywords
- heroin, opioid disorders, substance related disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 1995
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 21 Sep 1999 (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 purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
Detailed description
Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opiates | Experimental | Drug: opiatesOpiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM IV criteria for opioid dependence
- No major mood, psychotic, or anxiety disorder
- Physically healthy
- Able to perform study procedures
- 21-45 years of age
Key exclusion criteria (11 listed)
- DSM IV criteria for dependence on drugs other
- Participants requesting treatment
- Participants on parole or probation
- Pregnancy or lactation
- Birth, miscarriage or abortion with 6 months
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 |
|---|---|---|
| opiatesAlso: morphine, fentanyl, buprenorphine, oxycodoneprescription opioids | Drug | Opiates |
Primary outcome
Amount drug self-administered
Time frame: 90 minutes
All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward..
1 secondary outcome
Subjective responses
Time frame: 90 min
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 5 Jul 2017.
- Results publication: PubMed 17581533Comer SD, Sullivan MA, Whittington RA, Vosburg SK, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology. 2008 Apr;33(5):1179-91. doi: 10.1038/sj.npp.1301479. Epub 2007 Jun 20.
- Individual participant dataSharing planned: No
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.
Herbert Kleber, M.D. principal investigator
New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing opiates in people with Heroin Dependence and Opioid-Related Disorders, run by New York State Psychiatric Institute at 2 sites 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 7 inclusion and 11 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount drug self-administered (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000273, which also lists 1 linked publication.
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 5 Jul 2017.