Trial Of NS2359 For The Treatment of Cocaine Dependence
Condition: Cocaine Use Disorder
MeSH terms: Cocaine-Related Disorders
Intervention: NS2359; placebo
Intervention description: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.; Placebo pills identical in appearance to the NS2359 will be provided
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine,
      NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with
      nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated
      cocaine self-administration. In several phase II clinical trials for major depressive
      disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359
      exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine.
      In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg
      of cocaine, but it attenuated the both the rewarding and cardiovascular effects of
      intravenous cocaine. On the basis of these promising studies, investigators propose a Phase
      II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will
      involve 100 CA subjects participating in an eight week trial, including a 1-week baseline and
      8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication phase,
      there will be one follow-up visit. Subjects will be randomly assigned to treatment with
      placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse events. This
      dose range is selected on the basis of phase I and II evidence of tolerability and NS2359
      plasma levels which were associated with blockade of cocaine reward. This project has the
      potential to identify the first effective pharmacotherapy for CA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and females, 18-65 years old.

          2. Meets diagnostic criteria (DSM-V) for current diagnosis of cocaine use disorder,
             moderate to severe, by semi-structured interview.

          3. In the past 30 days, used no less than $100-worth of cocaine

          4. Speaks, understands, and prints in English.

        Exclusion Criteria:

          1. Meets DSM-V criteria for substance use disorder, moderate to severe, for a substance
             other than cocaine, alcohol or nicotine. Subjects with comorbid alcohol use disorder
             will be accepted if their alcohol use disorder is not severe enough to require a
             medical alcohol detoxification.

          2. Needs treatment with any psychoactive medications (with the exception of
             diphenhydramine or melatonin, if necessary, for sleep).

          3. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder,
             or organic mental disorder.

          4. Has another Axis I psychiatric disorder that in the opinion of the physician will
             interfere with completion of the study or place the patient at heightened risk through
             participation in the trial.

          5. Has evidence of a history of significant hematological, pulmonary, endocrine,
             cardiovascular, renal or gastrointestinal disease.

          6. Use of an investigational medication in the 30 days prior to randomization.

          7. Is female and has a positive pregnancy test, is contemplating pregnancy in the next 6
             months, is nursing, or is not using effective contraception (if relevant).

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