Pharmacologic MRI in Cocaine Addiction

Cocaine Dependence Clinical Trial

— phMRI  

Official title:

Pharmacologic MRI in Cocaine-addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652378
• Other study ID #: STU 122011-052
• Status: Completed
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: September 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas, Divison on Addictions	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood-oxygen-level-dependent contrast (BOLD)	change in BOLD response to drug infusion (ondansetron, lidocaine).	60 minutes after drug infusion