phMRI: Pharmacologic MRI in Cocaine Addiction

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01652378

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: ondansetron, lidocaine

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

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Pharmacologic MRI in Cocaine-addiction

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Zofran, Xylocaine

Arm

Intervention/Treatment

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 Names:

Zofran, Xylocaine

Control Participants

healthy control volunteers

Drug: ondansetron, lidocaine

Other Names:

Zofran, Xylocaine

Outcome Measures

Primary Outcome Measures

blood-oxygen-level-dependent contrast (BOLD) [60 minutes after drug infusion]
change in BOLD response to drug infusion (ondansetron, lidocaine).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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).