Pharmacologic MRI in Cocaine Addiction (phMRI)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: ondansetron, lidocaine |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Pharmacologic MRI in Cocaine-addiction |
- blood-oxygen-level-dependent contrast (BOLD) [ Time Frame: 60 minutes after drug infusion ] [ Designated as safety issue: No ]change in BOLD response to drug infusion (ondansetron, lidocaine).
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cocaine-Addicted Participants
Group of participants diagnosed with cocaine dependence
|
Drug: ondansetron, lidocaine
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). Other Name: Zofran, Xylocaine
|
|
Control Participants
healthy control volunteers
|
Drug: ondansetron, lidocaine
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). Other Name: Zofran, Xylocaine
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Other medical or psychiatric disorders that may effect neural functioning.
- Medications that may effect brain functioning
Contacts and Locations| United States, Texas | |
| UT Southwestern Medical Center at Dallas, Divison on Addictions | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Bryon Adinoff, M.D. 214-645-6975 bryon.adinoff@utsouthwestern.edu | |
| Contact: Robbi Banks 214-645-6975 robbi.banks@utsouthwestern.edu | |
| Principal Investigator: Bryon Adinoff, M.D. | |
| Principal Investigator: | Bryon Adinoff, M.D. | UT Southwestern Medical Center at Dallas |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01652378 History of Changes |
| Other Study ID Numbers: | STU 122011-052 |
| Study First Received: | June 12, 2012 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Texas Southwestern Medical Center:
|
cocaine addiction neuroimaging functional magnetic resonance imaging (fMRI) |
Additional relevant MeSH terms:
|
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Mental Disorders Cocaine Lidocaine Ondansetron Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anti-Arrhythmia Agents Antiemetics Autonomic Agents Gastrointestinal Agents Antipruritics |
ClinicalTrials.gov processed this record on May 22, 2013