Pharmacologic MRI in Cocaine Addiction

NCT ID: NCT01652378

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

Cocaine Dependence

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cocaine-Addicted Participants

Group of participants diagnosed with cocaine dependence

ondansetron, lidocaine

Intervention Type: DRUG

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).

Control Participants

healthy control volunteers

ondansetron, lidocaine

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Zofran, Xylocaine

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryon Adinoff, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center at Dallas

Locations

UT Southwestern Medical Center at Dallas, Divison on Addictions

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 122011-052

Identifier Type: -

Identifier Source: org_study_id