Complementary Combination Therapy for Cocaine Dependence

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will assess the impact of treatment with doxazosin and modafinil, alone and in combination, on the subjective and reinforcing effects of cocaine in non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid design in which participants will be randomized into two groups: placebo and doxazosin 8 mg/d. They will remain in their assigned group for the duration of the study. After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Armodafinil; Cocaine; Doxazosin; Modafinil

Criteria

Inclusion Criteria:

1. Be English-speaking volunteers who are not seeking treatment at the time of the study. We require proficiency in English to ensure good communication with staff

2. Be aged between 18 and 55 years

3. Meet DSM-IV TR criteria for cocaine dependence using the MINI

4. Have a self-reported history of using cocaine by the IV or smoked route

5. Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic

6. Have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exceptions: (a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) <3× the upper limit of normal and (b) kidney function tests (creatinine and BUN) <2× the upper limit of normal

7. Have a baseline ECG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias

8. Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator

Exclusion Criteria:

1. Have any history or evidence suggestive of seizure disorder or brain injury

2. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure

3. Meet criteria for current dependence on any drug other than cocaine or nicotine

4. Have neurological or psychiatric disorders, such as:

• psychosis, bipolar illness or major depression as assessed by MINI;

• organic brain disease or dementia assessed by clinical interview;

• history of any psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;

• and history of suicide attempts within the past year and/or current suicidal ideation/plan

5. Have evidence of clinically significant heart disease or hypertension, as determined by the PI

6. Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI

7. Have evidence of untreated or unstable medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease

8. Have HIV and are currently symptomatic or are taking antiretroviral medication

9. Be pregnant or nursing. Females must provide negative pregnancy urine tests upon hospital admission and at the end of study participation. Females must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide)

10. Have asthma or currently use theophylline or other sympathomimetics

11. Be taking a medication that potently inhibits CYP 3A4, as this enzyme metabolizes the study medications. Potent inhibitors include clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole

12. Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study