Pharmacologic MRI in Cocaine Addiction (phMRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01652378
First received: June 12, 2012
Last updated: January 4, 2013
Last verified: June 2012
  Purpose

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 Intervention Phase
Cocaine Dependence
Drug: ondansetron, lidocaine
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Pharmacologic MRI in Cocaine-addiction

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • blood-oxygen-level-dependent contrast (BOLD) [ Time Frame: 60 minutes after drug infusion ] [ Designated as safety issue: No ]
    change in BOLD response to drug infusion (ondansetron, lidocaine).


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Zofran, Xylocaine

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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with cocaine addiction will be recruited from patients requesting treatment for addiction at the Dallas VA Medical Center and Homeward Bound,Inc. Recently using cocaine patients and healthy controls will be recruited from flyers and internet ads.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652378

Locations
United States, Texas
UT Southwestern Medical Center at Dallas, Divison on Addictions Recruiting
Dallas, Texas, United States, 75390
Contact: Bryon Adinoff, M.D.    214-645-6975    bryon.adinoff@utsouthwestern.edu   
Contact: Robbi Banks    214-645-6975    robbi.banks@utsouthwestern.edu   
Principal Investigator: Bryon Adinoff, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Bryon Adinoff, M.D. UT Southwestern Medical Center at Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01652378     History of Changes
Other Study ID Numbers: STU 122011-052
Study First Received: June 12, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
cocaine addiction
neuroimaging
functional magnetic resonance imaging (fMRI)

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Lidocaine
Ondansetron
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on July 31, 2014