Cocaine-Related DisordersPhase 2NCT00000187
Ritanserin in Treatment of Cocaine Dependence - 1
A Phase 2 study testing Ritanserin in people with Cocaine-Related Disorders, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence. Read more about this study
- Who is it for?
- Ages 28 to 47 years, men only
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Ritanserin
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1992to Jun 1994
- 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 28 to 47 years
- Men only
- No healthy volunteers
- Adult
Please contact site for information.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104 6178
About this study
Official title: Ritanserin in Treatment of Cocaine Dependence
The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Ritanserin
- Keywords
- Cocaine Dependence, ritanserin
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitanserinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Cocaine craving
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 startJul 1992
- Primary completionJun 1994
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-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, James Cornish, University of Pennsylvania
- Investigators
- James Cornish, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000187
- Sponsor's protocol ID
- NIDA-00144-1
- Other IDs
- 3R01DA012268, K20-00144-1
- Status last verified
- May 2015
- First submitted
- 20 Sep 1999
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.
PubMed 11137283
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ritanserin in Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00000187
- Acronym / sponsor ID
- NIDA-00144-1
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Dependence, ritanserin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 1992
- Primary completion
- Jun 1994 (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 assess ritanserin as a pharmacotherapy for cocaine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 28 to 47 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Ritanserin | Drug | – |
Primary outcome
Cocaine use
Cocaine craving
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 28 May 2015.
- Background: PubMed 11137283Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.
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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.
James Cornish, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritanserin in people with Cocaine-Related Disorders, run by University of Pennsylvania 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?
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 28 May 2015. 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.
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?
Cocaine use. The study lists 2 primary outcomes in all. 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 NCT00000187, 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 28 May 2015.