Cocaine-Related DisordersPhase 2NCT00033033
Reserpine for the Treatment of Cocaine Dependence - 1
A Phase 2 study testing Reserpine in people with Cocaine-Related Disorders and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Reserpine
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2001to May 2003
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method
Who cannot join
- Additional criteria available during screening at the site.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston University Medical Center
Boston, Massachusetts, 02215
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Dayton VA Medical Center
Dayton, Ohio, 45428
About this study
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.
Read the detailed description
To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.
- Being tested
- Reserpine
- Keywords
- cocaine dependence
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReserpineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startJul 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cincinnati VA Medical Center
- Investigators
- Eugene Somoza, M.D., Ph.D., Principal investigator, Cincinnati VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033033
- Sponsor's protocol ID
- NIDA-CTO-0001-1
- Status last verified
- Aug 2008
- First submitted
- 5 Apr 2002
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.
PubMed 25969833Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.
PubMed 25938124
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00033033
- Acronym / sponsor ID
- NIDA-CTO-0001-1
- Keywords
- cocaine dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Cincinnati VA Medical Center
- Study start
- Jul 2001
- Study completion
- May 2003
- First posted
- 8 Apr 2002 (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 the efficacy and safety of reserpine for the treatment of cocaine dependence.
Detailed description
To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method
Key exclusion criteria (1 listed)
- Additional criteria available during screening at the site.
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 |
|---|---|---|
| Reserpine | Drug | – |
Primary outcome
Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement
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 12 Jan 2017.
- Derived from this study: PubMed 25969833Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.
- Derived from this study: PubMed 25938124Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.
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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.
Eugene Somoza, M.D., Ph.D. principal investigator
Cincinnati VA Medical Center
3 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 Reserpine in people with Cocaine-Related Disorders and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 3 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 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 12 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 3 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?
Cocaine use. The study lists 5 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 NCT00033033, which also lists 2 linked publications.
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 12 Jan 2017.