Cocaine DependencePhase 1NCT01651364
A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence
A Phase 1 study testing Cabergoline in people with Cocaine Dependence and Cocaine Abuse, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of treatment with cabergoline, compared to treatment with placebo, on cocaine induced craving and subjective effects in cocaine-dependent human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction
- What is being tested?
- Cabergoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2011
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be English-speaking volunteers who are not seeking treatment at the time of the study.
- Be between 18-55 years of age.
- Meet DSM-IV TR criteria for cocaine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most cocaine users smoke cigarettes.
- Have a self-reported history of using cocaine by the smoked or IV route.
- Have vital signs as follows: supine blood pressure > 100/65 mm Hg. To ensure that subjects will not be at risk from cocaine, the resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.
- Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) ≤ 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) within normal limits.
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- Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias.
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.
- Females must have a negative urine pregnancy test during screening and at followup, on day 22.
- Provide a negative urine test for cocaine metabolite on Day 1.
Who cannot join
- Meet DSM IV TR criteria for dependence on drugs other than cocaine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure.
- Have a history of heart valve disease.
- Have any evidence from physical exam of heart murmur.
- Have neurological or psychiatric disorders, such as: psychosis, bipolar illness or major depression as assessed by MINI; organic brain disease or dementia assessed by clinical interview; history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past year and/or current suicidal ideation/plan.
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- Have evidence of clinically significant heart disease or hypertension, as determined by the PI.
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.
- Have symptomatic HIV or are taking antiretroviral medication.
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation.
- Have asthma or currently use theophylline or other sympathomimetics.
- Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
- Criteria for Discontinuation Following Initiation:
- Inability to comply with study procedures.
- Meet discontinuation criteria due to exaggerated response to cocaine, described below.
- Use cocaine prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
The purpose of this study is to determine the effects of treatment with cabergoline, compared to treatment with placebo, on cocaine induced craving and subjective effects in cocaine-dependent human volunteers.
Read the detailed description
Secondary aims are to clarify the genetics of substance abuse, potentially leading to improved methods to diagnosis those at risk and to help develop better therapeutic interventions and to develop a new saliva-based test for the detection and measurement of drugs of abuse. As an additional aim, we will also collect blood samples for analyzing a number of genetic polymorphisms.
- Conditions
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction, Substance Abuse
- Being tested
- Placebo, Cabergoline
- Keywords
- Cocaine, Cabergoline
- 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.
PlaceboDrug
Also called Sugar pill
Enrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator.
CabergolineDrug
Also called Dostinex, Cabaser
Enrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cabergoline | Active comparator | Not described Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of treatment with cabergoline and cocaine on cardiovascular measures
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on cabergoline relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
Secondary outcomes (1)
The effects of treatment with cabergoline and cocaine on cocaine-induced craving and subjective effects
The ability of cabergoline, as compared to placebo, to reduce cocaine-induced craving and to reduce reinforcing effects produced by cocaine will be measured by: 1. VAS, Adjective Scales, and MCQ; 2. Choices for cocaine vs. money in the self-administration assay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Thomas Newton, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651364
- Sponsor's protocol ID
- H-27036
- Other IDs
- DPMC, 2630090202
- Status last verified
- Jul 2012
- First submitted
- 20 Feb 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01651364
- Acronym / sponsor ID
- H-27036
- Conditions
- Cocaine Dependence, Cocaine Abuse, Cocaine Addiction, Substance Abuse
- Keywords
- Cocaine, Cabergoline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jul 2012 (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 determine the effects of treatment with cabergoline, compared to treatment with placebo, on cocaine induced craving and subjective effects in cocaine-dependent human volunteers.
Detailed description
Secondary aims are to clarify the genetics of substance abuse, potentially leading to improved methods to diagnosis those at risk and to help develop better therapeutic interventions and to develop a new saliva-based test for the detection and measurement of drugs of abuse. As an additional aim, we will also collect blood samples for analyzing a number of genetic polymorphisms.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cabergoline | Active comparator | Drug: Cabergoline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be English-speaking volunteers who are not seeking treatment at the time of the study.
- Be between 18-55 years of age.
- Meet DSM-IV TR criteria for cocaine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most cocaine users smoke cigarettes.
- Have a self-reported history of using cocaine by the smoked or IV route.
- Have vital signs as follows: supine blood pressure > 100/65 mm Hg. To ensure that subjects will not be at risk from cocaine, the resting pulse must be < 90 bpm and the blood pressure must be < 150 mmHg systolic and < 90 mmHg diastolic.
Key exclusion criteria (16 listed)
- Meet DSM IV TR criteria for dependence on drugs other than cocaine or nicotine.
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure.
- Have a history of heart valve disease.
- Have any evidence from physical exam of heart murmur.
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 |
|---|---|---|
| PlaceboAlso: Sugar pillEnrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator. | Drug | Placebo |
| CabergolineAlso: Dostinex, CabaserEnrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly. | Drug | Cabergoline |
Primary outcome
The effects of treatment with cabergoline and cocaine on cardiovascular measures
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on cabergoline relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
1 secondary outcome
The effects of treatment with cabergoline and cocaine on cocaine-induced craving and subjective effects
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 27 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabergoline in people with Cocaine Dependence and Cocaine Abuse, run by Baylor College of Medicine 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 10 inclusion and 16 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 27 Jul 2012. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The effects of treatment with cabergoline and cocaine on cardiovascular measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2012.