A Pilot Study of Candesartan as a Treatment for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Candesartan with CBT; Placebo with CBT
Intervention description: 8 mg, po (by mouth)
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: cocaine; dependence; pharmacotherapy

Summary:

      The purpose of this study is to see if a drug called Candesartan will help to reduce use of
      cocaine.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for study entry, all subjects must satisfy the following criteria:

          1. Age 18 to 64 years inclusive;

          2. Females either must be of non-child bearing potential (i.e., surgically sterilized or
             postmenopausal) or must be using adequate contraception, have a negative pregnancy
             test, and must agree to continue to use such precautions for the duration of the
             study.

          3. Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV-TR)
             criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI
             and/or as per PI/study investigator's examination of the patient during screening.
             (Per DSM-IV-TR, principal diagnosis is the condition that is the primary target of
             treatment at the time of presentation);

          4. Motivated to discontinue or reduce cocaine use during the period of the study, as
             evidenced both by the judgment of the Investigator or designee and by the subject's
             compliance level with the requirement for attendance at clinic visits such that the
             urine sample requirements for inclusion criteria #6 is fully met;

          5. Has a positive pattern of cocaine usage as determined by provision of at least one
             cocaine positive urine sample (benzoylecgonine (BE) level at least 300 ng/ml) during
             the screening period; typically conducted over a 7-14 day period.

          6. In good general health as determined by self-reported and/or computer-based medical
             history, general clinical examination, and laboratory tests;

          7. Has provided written informed consent.

          8. Are cooperative, willing and able to participate and adhere to the protocol
             requirements

        Exclusion Criteria:

        Subjects will be excluded from the study if one or more of the following statements are
        applicable:

          1. Subject is taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril
             (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in
             Lexxel, in Vaseretic), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in
             Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon),
             quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril
             (Mavik, in Tarka); lithium (Eskalith Controlled-Release, Eskalith, Lithobid);

          2. Subject is on psychotropic medications, an MAOI, or an opiate antagonist;

          3. Subject is currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or
             other central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase
             inhibitor (MAOI); or an opiate antagonist;

          4. Subject has an unstable medical, neurologic, or psychiatric illness that would
             interfere with the subject's safety, ability to participate in the study, or the
             interpretability of data. Subjects who meet the DSM-IV-R criteria for psychosis,
             schizophrenia, bipolar disorder or clinically significant suicidal ideation as
             assessed by the PI/study investigator and/or the MINI will be excluded. Subjects who
             have been taking stable doses of antidepressants for at least 3 months at the time the
             consent is signed will be allowed onto the study unless those antidepressants are of
             the types specified under exclusion criteria #3,above;

          5. Subject is dependent on benzodiazepines, barbiturates, amphetamines, opiates
             (including methadone or buprenorphine maintenance treatment) according to the DSM-IV-R
             and as assessed by the PI/study investigator and/or the MINI; 6

          6. Subject is, in the investigator's opinion, at risk of requiring medical detoxification
             for alcohol dependence during the study;

          7. Subject has participated in another clinical trial or received any other
             investigational compound within 7 days prior to being randomized into this study;

          8. Significant medical conditions (e.g., major cardiovascular, renal, endocrine, hepatic
             disorders, immunosuppressive disorders) such as abnormal liver function (with
             laboratory findings of serum glutamic oxaloacetic transaminase (SGOT) or serum
             glutamic-pyruvic transaminase (SGPT) greater than three times normal), hypotension,
             hypertension, a current cardiac condition, and those having a high risk of
             cardiovascular disease, seizure disorder, or another significant underlying medical
             condition which would contraindicate Candesartan treatment;

          9. Upon review of a compilation of screening data, at the discretion of the PI/study
             investigator, a participant may be excluded from the study if they test positive
             during the screening process for any substance other than cocaine or marijuana;

         10. Female subjects with a positive pregnancy test, lactating mothers, women refusing to
             agree to pregnancy tests during the study, women who are planning to become pregnant
             during the period of the trial or women of child-bearing potential who refuse to agree
             to use adequate contraception during the study. Acceptable contraceptive methods are
             oral or parenteral hormonal contraceptives, intrauterine device (IUD), or barrier and
             spermicide, but not abstinence; OR Male subjects refusing to agree to use adequate
             contraception during the study, or males who are part of a couple planning to become
             pregnant during the period of the trial;

         11. Any other factor that per the Investigator/designee would make the subject unsafe or
             unsuitable for the study.