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Completed

NCT Number: NCT01652378

Pharmacologic MRI in Cocaine Addiction

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).

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center at Dallas, Divison on Addictions

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron, lidocaine

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).

Other names: Zofran, Xylocaine

Primary outcomes

  1. blood-oxygen-level-dependent contrast (BOLD)

    Time frame: 60 minutes after drug infusion

    change in BOLD response to drug infusion (ondansetron, lidocaine).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Pharmacologic MRI in Cocaine-addiction

Acronym: phMRI

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2012
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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