Back to resultsStriatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levodopa/carbidopa 400/100 BID
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring drug abuse, cocaine, impulsivity, dopamine
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects
- Age 18 to 50
- Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
Exclusion Criteria:
- Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
- Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- Significant current suicidal or homicidal ideation
- Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
- Taking CNS active concomitant medications
- Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
- Having conditions of probation or parole requiring reports of drug use to officers of the court
- Impending incarceration
- Pregnant or breast feeding for female patients
- Inability to read, write, or speak English
- Having plans to leave the immediate geographical area within 3 months
- Unwillingness or not competent to sign a written informed consent form
- Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
- Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
- Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Experimental
Arm Label
Healthy Control
Placebo
Medication
Arm Description
Non drug using healthy controls
Placebo BID for 7 weeks
Levodopa/carbidopa 400/100 BID for 7 weeks
Outcomes
Primary Outcome Measures
Cocaine Treatment Outcome
Treatment effectiveness score based on number of positive urine drug screens
Secondary Outcome Measures
Full Information
NCT ID
NCT02080819
First Posted
March 4, 2014
Last Updated
March 16, 2018
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02080819
Brief Title
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Official Title
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 21, 2017 (Actual)
Study Completion Date
January 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project proposes to investigate the role of brain connectivity in the mechanism of treatment response to dopaminergic medications in cocaine dependence.
Detailed Description
This project will use stochastic DCM, which is a recent DCM extension that takes into account hidden fluctuations in neuronal and vascular responses, and thus is especially suited for investigating effects of disease or drugs. In addition, this project will use nonlinear DCM, a DCM extension that can measure gating effects by striatum on cortico-cortical pathways. The overall aims of this project are: (1) To conduct functional magnetic resonance imaging-based DCM studies of working memory and impulsivity in order to determine the effective (directional) connectivity between PFC and striatum in treatment-seeking Cocaine Dependent (CD) subjects compared to non-drug using controls. We hypothesize that DLPFC causally affects ventral striatum in CDs, and that the strength of this connection is lower in CDs compared to controls. (2) To determine whether the pretreatment gating effect by the dorsal striatum, as a reflection of pretreatment hypodopaminergic state associated with chronic compulsive drug use, predicts the treatment response to dopaminergic pharmacotherapy in CDs. We hypothesize that lower pretreatment gating by the dorsal striatum on prefrontal-parietal effective connectivity predicts greater 8-week improvement from treatment of CDs with DA enhancing medications (combined with cognitive behavioral therapy [CBT]), but not from treatment with placebo (combined with CBT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
drug abuse, cocaine, impulsivity, dopamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Non drug using healthy controls
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo BID for 7 weeks
Arm Title
Medication
Arm Type
Experimental
Arm Description
Levodopa/carbidopa 400/100 BID for 7 weeks
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa 400/100 BID
Other Intervention Name(s)
Sinemet, Parcopa
Intervention Description
Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
Primary Outcome Measure Information:
Title
Cocaine Treatment Outcome
Description
Treatment effectiveness score based on number of positive urine drug screens
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects
Age 18 to 50
Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
Exclusion Criteria:
Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangsuo Ma, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
We'll reach out to this number within 24 hrs