- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080819
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Healthy Control
Non drug using healthy controls
|
|
Placebo Comparator: Placebo
Placebo BID for 7 weeks
|
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.
Other Names:
|
Experimental: Medication
Levodopa/carbidopa 400/100 BID for 7 weeks
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine Treatment Outcome
Time Frame: Baseline to 12 weeks
|
Treatment effectiveness score based on number of positive urine drug screens
|
Baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Liangsuo Ma, Ph.D., Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
Other Study ID Numbers
- HM20000079
- 1R01DA034131 (U.S. NIH Grant/Contract)
- PT109865 (Other Identifier: Virginia Commonwealth University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cocaine Dependence
-
W. Michael HootenNational Institute on Drug Abuse (NIDA)Recruiting
-
University of ArkansasNational Institute on Drug Abuse (NIDA); Baylor College of MedicineCompleted
-
University of CincinnatiNational Institute on Drug Abuse (NIDA)CompletedNicotine Dependence | Cocaine Dependence | Methamphetamine DependenceUnited States
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)Completed
-
Tong LeeNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)CompletedCocaine Dependence | Methamphetamine DependenceUnited States
-
The University of Texas Health Science Center,...National Institute on Drug Abuse (NIDA)RecruitingAlcohol Dependence | Substance Abuse | Cocaine Dependence | Opiate Dependence | Cocaine AbuseUnited States
-
Johns Hopkins UniversityCompletedBehavior, Addictive | Heroin Dependence | Opioid Dependence | Cocaine Dependence | Cocaine AbuseUnited States
-
University of PennsylvaniaCompletedCocaine DependenceUnited States
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)CompletedOpioid-Related Disorders | Heroin Dependence | Cocaine Abuse or DependenceUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine Use Disorder | Cocaine Use Disorder | Cocaine Dependence | Methamphetamine Dependence | Stimulant Use Disorder | Methamphetamine Abuse | Cocaine Abuse | Stimulant Abuse | Stimulant UseUnited States
Clinical Trials on levodopa/carbidopa 400/100 BID
-
Snyder, Robert W., M.D., Ph.D., P.C.WithdrawnAge-related Macular DegenerationUnited States
-
Desitin Arzneimittel GmbHCompleted
-
Snyder, Robert W., M.D., Ph.D., P.C.Completed
-
Snyder, Robert W., M.D., Ph.D., P.C.Snyder Biomedical CorporationCompleted
-
XenoPort, Inc.CompletedParkinson's DiseaseUnited States
-
Snyder, Robert W., M.D., Ph.D., P.C.Completed
-
University of MinnesotaNot yet recruitingIdiopathic Parkinson DiseaseUnited States
-
Vanderbilt University Medical CenterUniversity of Pittsburgh; Emory University; Rutgers University; University of Pittsburgh...RecruitingDepressive Disorder, Treatment-Resistant | Cognitive Decline | Late Life Depression | Gait Impairment | LevodopaUnited States
-
University of MichiganNational Institute on Aging (NIA)RecruitingParkinsonian Signs in Older PersonsUnited States
-
AbbVie (prior sponsor, Abbott)Completed