Cocaine DependenceNCT00451230
Metabolic Effects of Cocaine
A study testing cocaine and hydrocortisone in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence Read more about this study
- Who is it for?
- Ages 21 to 49 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- cocaine and hydrocortisone
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2005
- 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 21 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with DSM IV diagnosis of cocaine dependence, medically healthy
Who cannot join
- Other than cocaine dependence DSM-IV axis I diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02116
About this study
Official title: Elucidating the Role of the Hypothalamic-Pituitary-Adrenal (HPA) Axis in the Mechanisms Underlying Cocaine Dependence
The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence
- Conditions
- Cocaine Dependence
- Being tested
- cocaine, hydrocortisone
- Keywords
- craving, insulin, leptin
- Medical subject headings
- Cocaine-Related Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cocaineDrug
hydrocortisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJun 2005
- Primary completionJun 2005
- Study completionJun 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 Cocaine 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Investigators
- Igor Elman, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451230
- Sponsor's protocol ID
- 2000p 000323
- Other IDs
- DA#14410
- Status last verified
- Oct 2002
- First submitted
- 22 Mar 2007
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rott D, Langleben DD, Elman I. Cocaine decreases plasma insulin concentrations in non-diabetic subjects: a randomized double-blind study. Diabet Med. 2008 Apr;25(4):510-1. doi: 10.1111/j.1464-5491.2008.02412.x. Epub 2008 Mar 13. No abstract available.
PubMed 18346162
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of the Hypothalamic-Pituitary-Adrenal (HPA) Axis in the Mechanisms Underlying Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00451230
- Acronym / sponsor ID
- 2000p 000323
- Conditions
- Cocaine Dependence
- Keywords
- craving, insulin, leptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Jun 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 23 Mar 2007 (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 goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with DSM IV diagnosis of cocaine dependence, medically healthy
Key exclusion criteria (1 listed)
- Other than cocaine dependence DSM-IV axis I diagnosis
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 |
|---|---|---|
| cocaine | Drug | – |
| hydrocortisone | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Jan 2017.
- Derived from this study: PubMed 18346162Rott D, Langleben DD, Elman I. Cocaine decreases plasma insulin concentrations in non-diabetic subjects: a randomized double-blind study. Diabet Med. 2008 Apr;25(4):510-1. doi: 10.1111/j.1464-5491.2008.02412.x. Epub 2008 Mar 13. No abstract available.
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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.
Igor Elman principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cocaine and hydrocortisone in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) 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 1 inclusion and 1 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 18 Jan 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451230, 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 18 Jan 2017.