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Pharmacologic MRI in Cocaine Addiction

Pharmacologic MRI in Cocaine-addiction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01652378
Acronym
phMRI
Enrollment
12
Registered
2012-07-30
Start date
2012-08-31
Completion date
2016-08-31
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence

Keywords

cocaine addiction, neuroimaging, functional magnetic resonance imaging (fMRI)

Brief 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).

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.

Interventions

DRUGondansetron, 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).

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
blood-oxygen-level-dependent contrast (BOLD)60 minutes after drug infusionchange in BOLD response to drug infusion (ondansetron, lidocaine).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026