Phase 3
Completed N=23
Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence
Cocaine Dependence
Source: ClinicalTrials.gov NCT01468012 ↗
Enrolled (actual)
23
Serious AEs
8.7%
Results posted
Dec 2016
Primary outcomePrimary: Cocaine Urine Toxicology
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Urine Toxicology |
— | — |
| PRIMARY Retention in Treatment |
7; 9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult, age 21-50.
- Meets DSM-IV criteria for current cocaine dependence, supported by a positive urine for cocaine metabolites
- Voluntarily seeking treatment for cocaine dependence
- Absence of other medical or psychiatric disorders that are unstable and would interfere with participation.
- Absence of any suspicious skin changes, suggestive of melanoma, during the full body exam
- Able to give informed consent.
Exclusion Criteria
- Current DSM-IV criteria of other substance use disorders with the exception of nicotine dependence, and mild to moderate alcohol or cannabis abuse or dependence. Alcohol or cannabis abuse or dependence may be included provided that cocaine is the predominant problem, and medical detoxification is not indicated; alcohol and cannabis use are common among cocaine dependent patients and their categorical exclusion would impede recruitment and result in a sample of limited generalizability; secondary analyses will explore whether they exert any moderating effects on the main findings.
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV organic mental disorder, psychotic disorder, bipolar disorder, recurrent severe MDD, OCD, or eating disorder. Participants with depressive disorder (provided that the score on the Hamilton Depression Scale is less than 20) and those with ADHD symptoms may be included, since these are common, often reflect effects of chronic drug use, and may improve with behavioral treatment and cessation or reduction of drug use.
- Unstable medical disorders, or medical disorders that might interfere with study participation, including seizure disorder.
- Significant current suicidal risk or 1 or more suicide attempts within the past year
- Concurrent treatment with psychotropic medications
- Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
- Baseline systolic BP of > 140 and 90 and 140 and 90 and < 60 and baseline HR greater than 90.
- Any clinically significant heart abnormality or cardiovascular disease
- History of allergic reaction or adverse reaction to study medications (methylphenidate; raclopride).
- Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" by Shellock
- Individuals who are predominantly left handed. Based on a score <50 on the Edinburg Handed Inventory (E.H.I.).
Data sourced from ClinicalTrials.gov (NCT01468012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.