Cocaine DependencephMRINCT01652378
Pharmacologic MRI in Cocaine Addiction
An observational study of Cocaine Dependence, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In the proposed study, the investigators will assess the brain response to medication probes the investigators have previously studied with SPECT. The brain response to ondansetron and lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI (fcMRI). Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- ondansetron, lidocaine
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2016
- Phase
- Observational
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with cocaine addiction will be recruited from patients requesting treatment for addiction at the Dallas VA Medical Center and Homeward Bound,Inc. Recently using cocaine patients and healthy controls will be recruited from flyers and internet ads.
Who may be able to join
- Cocaine dependence (cocaine patients)
- identify cocaine as their present primary drug of use
- Patients must have used cocaine within the previous 4 weeks (by patient history) and be abstinent for at least 1 week.
- No drug dependence (healthy control population).
Who cannot join
- Other medical or psychiatric disorders that may effect neural functioning.
- Medications that may effect brain functioning
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center at Dallas, Divison on Addictions
Dallas, Texas, 75390
About this study
Official title: Pharmacologic MRI in Cocaine-addiction
In the proposed study, the investigators will assess the brain response to medication probes the investigators have previously studied with SPECT. The brain response to ondansetron and lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI (fcMRI).
Read the detailed description
An extensive effort has been mounted to understand the neurobiologic mechanisms involved in the development and persistence of cocaine addiction and tendency to relapse. Although the last two decades have resulted in an explosion in our understanding of the biological mechanisms of reward, establishing the relevance of this knowledge to the addictive process has been problematic. Most importantly, this information has been of limited utility in offering new pharmacologic treatment approaches to addicted patients - particularly those with cocaine addiction. Over the past 15 years our laboratory has published multiple studies using pharmacologic probes to explore the biologic underpinnings of cocaine addiction using single photon emissions computerized tomography (SPECT) technology. More recently, however, functional magnetic resonance imaging (fMRI) has offered several advantages over SPECT and is now a favored approach, e.g. fMRI allows the continuous measurement of neural responses rather than a very limited time period with SPECT (1-3 minutes every 48 hours). Using fMRI [including both ASL (Arterial Spin Labeling) and fcMRI (functional connectivity], the neural response can be measured throughout the 60 min that follows infusion, allowing identification and capture of the maximal brain response period that may occur at any time during this 60 min. In the proposed study, we will assess the brain response to two of the probes (scopolamine and lidocaine) we have previously studied with SPECT.
- Conditions
- Cocaine Dependence
- Being tested
- ondansetron, lidocaine
- Keywords
- cocaine addiction, neuroimaging, functional magnetic resonance imaging (fMRI)
- 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.
ondansetron, lidocaineDrug
Also called Zofran, Xylocaine
Ondansetron: Ondansetron (0.15 mg/kg) will be administered through the IV line over 15 min at a constant rate of infusion.
Lidocaine: Lidocaine will be administered as a 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg/kg/hour for 55 min (60 min total infusion).
| Study group | Role | What they receive |
|---|---|---|
| Cocaine-Addicted Participants | Group of participants diagnosed with cocaine dependence Receives: Drug: ondansetron, lidocaine | |
| Control Participants | healthy control volunteers Receives: Drug: ondansetron, lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood-oxygen-level-dependent contrast (BOLD)
change in BOLD response to drug infusion (ondansetron, lidocaine).
Measured: 60 minutes after drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2016
- Study completionAug 2016
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 University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryon Adinoff, M.D., Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652378
- Sponsor's protocol ID
- STU 122011-052
- Acronym
- phMRI
- Status last verified
- Sep 2019
- First submitted
- 12 Jun 2012
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic MRI in Cocaine-addiction
- ClinicalTrials.gov ID
- NCT01652378
- Acronym / sponsor ID
- phMRI / STU 122011-052
- Conditions
- Cocaine Dependence
- Keywords
- cocaine addiction, neuroimaging, functional magnetic resonance imaging (fMRI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 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.
In the proposed study, the investigators will assess the brain response to medication probes the investigators have previously studied with SPECT. The brain response to ondansetron and lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI (fcMRI).
Detailed description
An extensive effort has been mounted to understand the neurobiologic mechanisms involved in the development and persistence of cocaine addiction and tendency to relapse. Although the last two decades have resulted in an explosion in our understanding of the biological mechanisms of reward, establishing the relevance of this knowledge to the addictive process has been problematic. Most importantly, this information has been of limited utility in offering new pharmacologic treatment approaches to addicted patients - particularly those with cocaine addiction. Over the past 15 years our laboratory has published multiple studies using pharmacologic probes to explore the biologic underpinnings of cocaine addiction using single photon emissions computerized tomography (SPECT) technology. More recently, however, functional magnetic resonance imaging (fMRI) has offered several advantages over SPECT and is now a favored approach, e.g. fMRI allows the continuous measurement of neural responses rather than a very limited time period with SPECT (1-3 minutes every 48 hours). Using fMRI [including both ASL (Arterial Spin Labeling) and fcMRI (functional connectivity], the neural response can be measured throughout the 60 min that follows infusion, allowing identification and capture of the maximal brain response period that may occur at any time during this 60 min. In the proposed study, we will assess the brain response to two of the probes (scopolamine and lidocaine) we have previously studied with SPECT.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocaine-Addicted Participants | – | Drug: ondansetron, lidocaineGroup of participants diagnosed with cocaine dependence |
| Control Participants | – | Drug: ondansetron, lidocainehealthy control volunteers |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with cocaine addiction will be recruited from patients requesting treatment for addiction at the Dallas VA Medical Center and Homeward Bound,Inc. Recently using cocaine patients and healthy controls will be recruited from flyers and internet ads.
Key inclusion criteria (4 listed)
- Cocaine dependence (cocaine patients)
- identify cocaine as their present primary drug of use
- Patients must have used cocaine within the previous 4 weeks (by patient history) and be abstinent for at least 1 week.
- No drug dependence (healthy control population).
Key exclusion criteria (2 listed)
- Other medical or psychiatric disorders that may effect neural functioning.
- Medications that may effect brain functioning
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 |
|---|---|---|
| ondansetron, lidocaineAlso: Zofran, XylocaineOndansetron: Ondansetron (0.15 mg/kg) will be administered through the IV line over 15 min at a constant rate of infusion. Lidocaine: Lidocaine will be administered as a 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg/kg/hour for 55 min (60 min total infusion). | Drug | Cocaine-Addicted Participants, Control Participants |
Primary outcome
blood-oxygen-level-dependent contrast (BOLD)
Time frame: 60 minutes after drug infusion
change in BOLD response to drug infusion (ondansetron, lidocaine).
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 9 Sep 2019.
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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.
Bryon Adinoff, M.D. principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Dependence, run by University of Texas Southwestern Medical Center 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 4 inclusion and 2 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 9 Sep 2019. 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.
What does the primary outcome measure?
blood-oxygen-level-dependent contrast (BOLD) (time frame: 60 minutes after drug infusion). 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 9 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.