Cocaine-Related DisordersPhase 2NCT00223626
Topiramate to Reduce Cocaine Dependence
A Phase 2 study testing Topiramate in people with Cocaine-Related Disorders, run by Bankole Johnson at 2 sites in United States.
Trial summary
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the ability to diminish cocaine cravings in addicts. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Dec 2010
- 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
- Meets DSM-IV-TRTM diagnostic criteria for cocaine dependence
- Subjects must be non-treatment seeking, cocaine-dependent or cocaine-abusing individuals who report taking cocaine at least once a month
- In generally good health as confirmed by medical history, physical examination, electrocardiogram, laboratory screening tests, and vital signs
- Must be able to take oral medication, adhere to the medication regimens, and be willing to return to the clinic for regular study visits
- Must be able to read and understand all instructions, rating scales, and questionnaires in English
- Must be willing to stay overnight at the University Clinical Psychopharmacology Laboratory (UCPL)
- Must comply with the alcohol, tobacco, and drug-free environment regulations at the UCPL
- If female, must be postmenopausal for at least 1 year, surgically sterile, or willing to use contraception throughout the study
Who cannot join
- History of mental illness, other than cocaine or nicotine dependence
- History of mental retardation or neuropsychological functioning greater than 1.5 standard deviation below expected rang.
- Clinically significant abnormalities found on the electrocardiogram
- History of hypertension (blood pressure greater than 140/90 mm Hg) or systolic hypotension (blood pressure less than 90/75 mm Hg)
- Resting pulse rate of greater than 90 beats per minute
- Cerebrovascular accident or transient ischemic attack
Show all 31Show fewer
- Ischemic heart disease or heart attack
- Symptomatic coronary artery disease or peripheral vascular disease
- Cancer or history of cancer within the 5 years of study entry (other than basal cell carcinoma)
- Kidney disease and/or impaired kidney function, as defined by an estimated creatinine clearance of 60 mL per minute
- Gastrointestinal system disease, including active liver disease or current active hepatitis; subjects with AST and/or ALT levels greater than four times the upper limit of the normal range and/or an increased total serum bilirubin level greater than two times the upper limit of normal at screening
- Endocrinological disorders, including thyroid disorders
- Glaucoma
- Gross neurological disorders, including seizure disorders and progressive or degenerative neurological disorders (e.g., multiple sclerosis)
- History of nephrolithiasis
- Clinically significant laboratory screening test results on hematology, chemistry, or urine analysis; up to four times above the normal range of the following will be allowed unless there is evidence of hepatocellular disease or failure: liver enzymes (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltransferase (GGT), blood urea nitrogen (BUN), lactate dehydrogenase (LDH)
- Any disease or condition that compromises the function of body systems that may result in altered absorption, excess accumulation, or impaired metabolism or excretion of topiramate
- Current use of psychoactive drugs, including sympathomimetics, caffeinated drinks in excess of 500 mg per day, and tobacco consumption of greater than 0.75 grams per day (approximately 25 cigarettes per day); non-pathological levels of alcohol consumption is permitted
- Suicide attempt or suicidal thoughts within 30 days of study entry
- Evidence of behavioral toxicity, including seizures, severe agitation, or psychosis
- Be taking a medication that could interact adversely with topiramate, unless the medication is discontinued.
- History of any severe or life-threatening medication interactions
- Currently taking any prescribed medications for heart or cerebrovascular disease
- Currently taking any medication with potential interactions with cocaine or topiramate, including glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g., fluoxetine), serotonin antagonists (e.g., ritanserin or buspirone), other antidepressants (e.g., tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g., haloperidol), calcium channel antagonists (e.g., isradipine), compounds with actions similar to disulfiram (Antabuse), or any carbonic anhydrase medication or medication containing triamterene
- Previously treated with topiramate for any reason and discontinued treatment due to an adverse event or a hypersensitivity reaction to topiramate
- Participation deemed unsafe because of precautions, warnings, or contraindications outlined in the topiramate investigator brochure and/or package insert, as determined by study investigator
- Expected to stay in a restricted environment or awaiting imprisonment
- Currently living in the same household as another study participant
- Received an investigational drug or device or participated in a clinical trial in the 30 days prior to study entry
- Employee of the investigator or study center
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia CARE Center for Addiction Research & Education
Charlottesville, Virginia, 22911
UVA CARE Richmond
Richmond, Virginia, 23294
About this study
Official title: Lab Trials to Develop Medication for Cocaine Dependence
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to determine the effectiveness of topiramate in reducing cocaine's rewarding effects in individuals addicted to cocaine.
Read the detailed description
GABA is an inhibitory neurotransmitter that is found primarily in the brain. High GABA levels result in low levels of dopamine, another neurotransmitter that is the brain's "feel good" chemical and which plays a primary role in cocaine drug addiction. Cravings for cocaine can be reduced by lowering dopamine levels. This makes topiramate, a GABA-altering medication, a potential treatment for cocaine addiction. This study will evaluate the subjective, behavioral, and physiological effects of topiramate in individuals addicted to cocaine.
Potential participants will initially attend a 4- to 6-hour screening session. This will include review of medical and drug histories, standardized psychological questionnaires, a physical exam, and blood collection. Eligible participants will then be admitted to the inpatient clinic. During the first day of experiment, participants will receive instructions and information about the study procedures. They will also undergo a physical exam, an electrocardiogram, standardized psychological questionnaires, and blood and urine collection. A single test dose of cocaine will be administered intravenously to all participants to ensure safety with continuation in the study. Vital signs will be monitored hourly throughout the day.
The experiment will last 25 days and will enroll 24 individuals addicted to cocaine. In this three-part experiment, participants will be admitted to the inpatient clinic for an 8-day study session. Following this session, they will be discharged from the clinic for a 1-week washout phase. Participants will then return to the inpatient clinic for another 8-day study session. The two study sessions will be identical. During both sessions, participants will first receive topiramate or placebo for 4 consecutive days. While continuing to receive topiramate or placebo, participants will then also receive intravenous cocaine or placebo for 3 consecutive days.Participants will be monitored by the study physician. Electrocardiograms will be used to monitor heart activity, and blood will be drawn frequently to monitor levels of cocaine and topiramate. Participants will complete standardized questionnaires several times each day to assess mood changes and cognitive function.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Topiramate
- Keywords
- Cocaine Addiction, Cocaine Dependence
- 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.
TopiramateDrug
Also called Topamax
the maximum topiramate test dose is 200 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Not described Receives: Drug: Topiramate |
| Placebo | Placebo comparator | Not described Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine-induced mood changes
Measured: measured throughout cocaine and topiramate testing sessions
Effects of topiramate on cognitive function
Measured: measured throughout cocaine and topiramate testing sessions
Drug safety
Measured: measured throughout cocaine and topiramate testing sessions
Cardiovascular response to cocaine (measured throughout cocaine and topiramate testing sessions)
Measured: measured throughout cocaine and topiramate testing sessions
Secondary outcomes (1)
Physiological response (measured throughout cocaine and topiramate testing sessions)
Measured: measured throughout cocaine and topiramate testing sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bankole Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Bankole Johnson, University of Virginia
- Investigators
- Bankole A. Johnson, DSc,MD.PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223626
- Sponsor's protocol ID
- 12350
- Other IDs
- R01DA012191, DPMCDA
- Status last verified
- Apr 2012
- First submitted
- 13 Sep 2005
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lab Trials to Develop Medication for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00223626
- Acronym / sponsor ID
- 12350
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bankole JohnsonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Sep 2005 (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.
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Topiramate, a medication which lowers dopamine levels, may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to determine the effectiveness of topiramate in reducing cocaine's rewarding effects in individuals addicted to cocaine.
Detailed description
GABA is an inhibitory neurotransmitter that is found primarily in the brain. High GABA levels result in low levels of dopamine, another neurotransmitter that is the brain's "feel good" chemical and which plays a primary role in cocaine drug addiction. Cravings for cocaine can be reduced by lowering dopamine levels. This makes topiramate, a GABA-altering medication, a potential treatment for cocaine addiction. This study will evaluate the subjective, behavioral, and physiological effects of topiramate in individuals addicted to cocaine.
Potential participants will initially attend a 4- to 6-hour screening session. This will include review of medical and drug histories, standardized psychological questionnaires, a physical exam, and blood collection. Eligible participants will then be admitted to the inpatient clinic. During the first day of experiment, participants will receive instructions and information about the study procedures. They will also undergo a physical exam, an electrocardiogram, standardized psychological questionnaires, and blood and urine collection. A single test dose of cocaine will be administered intravenously to all participants to ensure safety with continuation in the study. Vital signs will be monitored hourly throughout the day.
The experiment will last 25 days and will enroll 24 individuals addicted to cocaine. In this three-part experiment, participants will be admitted to the inpatient clinic for an 8-day study session. Following this session, they will be discharged from the clinic for a 1-week washout phase. Participants will then return to the inpatient clinic for another 8-day study session. The two study sessions will be identical. During both sessions, participants will first receive topiramate or placebo for 4 consecutive days. While continuing to receive topiramate or placebo, participants will then also receive intravenous cocaine or placebo for 3 consecutive days.Participants will be monitored by the study physician. Electrocardiograms will be used to monitor heart activity, and blood will be drawn frequently to monitor levels of cocaine and topiramate. Participants will complete standardized questionnaires several times each day to assess mood changes and cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramate |
| Placebo | Placebo comparator | Drug: Topiramate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Meets DSM-IV-TRTM diagnostic criteria for cocaine dependence
- Subjects must be non-treatment seeking, cocaine-dependent or cocaine-abusing individuals who report taking cocaine at least once a month
- In generally good health as confirmed by medical history, physical examination, electrocardiogram, laboratory screening tests, and vital signs
- Must be able to take oral medication, adhere to the medication regimens, and be willing to return to the clinic for regular study visits
- Must be able to read and understand all instructions, rating scales, and questionnaires in English
Key exclusion criteria (31 listed)
- History of mental illness, other than cocaine or nicotine dependence
- History of mental retardation or neuropsychological functioning greater than 1.5 standard deviation below expected rang.
- Clinically significant abnormalities found on the electrocardiogram
- History of hypertension (blood pressure greater than 140/90 mm Hg) or systolic hypotension (blood pressure less than 90/75 mm Hg)
- Resting pulse rate of greater than 90 beats per minute
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 |
|---|---|---|
| TopiramateAlso: Topamaxthe maximum topiramate test dose is 200 mg/d. | Drug | Placebo, Topiramate |
Primary outcome
Cocaine-induced mood changes
Time frame: measured throughout cocaine and topiramate testing sessions
Effects of topiramate on cognitive function
Time frame: measured throughout cocaine and topiramate testing sessions
Drug safety
Time frame: measured throughout cocaine and topiramate testing sessions
Cardiovascular response to cocaine (measured throughout cocaine and topiramate testing sessions)
Time frame: measured throughout cocaine and topiramate testing sessions
1 secondary outcome
Physiological response (measured throughout cocaine and topiramate testing sessions)
Time frame: measured throughout cocaine and topiramate testing sessions
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 19 Apr 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.
Bankole A. Johnson, DSc,MD.PhD principal investigator
University of Virginia
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 Topiramate in people with Cocaine-Related Disorders, run by Bankole Johnson 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 8 inclusion and 31 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 19 Apr 2012. 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. 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 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-induced mood changes (time frame: measured throughout cocaine and topiramate testing sessions). The study lists 4 primary outcomes in all. 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 19 Apr 2012.