Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00780702
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age between 18 and 60
2. Evidence of physical dependence on opioids (determined by self-report, urine screen, and physical exam)
3. Evidence of (a) current cocaine use (determined by self-report and urine screen) or (b) cocaine dependence (DIS interview for DSM-IV criteria).
4. Lifetime drug-use duration of at least 1 year and current cocaine use on at least 3 days of the last 30.
5. Seeking treatment for opiate and cocaine use.
6. Able to attend methadone clinic 7 days/week.
EXCLUSION CRITERIA:
1. Any medical illness that in the view of the investigators would compromise participation in research (determined by Self-Reported Medical History; Physical Examination; Blood and Urine Laboratory tests; see details under Screening measures below), including, but not limited to:
* cardiovascular disease
* cerebrovascular disease
* unexplained history of syncope
* history of seizures, except for febrile seizures at childhood
* chronic renal failure, as estimated by Cr \> 2.0
* diabetes mellitus
* hyperlipidemia
2. Allergy, hypersensitivity, or intolerance to either methadone or aripiprazole (determined by Self-Reported Medical History)
3. AIDS, CD4 \<200, or evidence of severely compromised immune system (determined by Blood Laboratory tests; see details under Screening measures below)
4. Pregnancy or breastfeeding (Urine Pregnancy Test; self report)
5. Orthostatic hypotension (i.e., upon standing for 3 minutes, a 20 mm Hg decrease in systolic blood pressure or a 10 mmHg decrease in diastolic blood pressure, accompanied by an increase by 20 bpm in heart rate) on two separate readings during physical examination.
6. Marked, sustained high blood pressure (SBP \>160 mm Hg, DBP \>100 mm Hg) on two or more readings at a single visit and confirmed with two readings on a follow-up visit. If a participant is started on antihypertensive drugs at the start of the study, the participant may be cleared, but will not be started on aripiprazole until confirmation that the hypertension is well controlled (systolic blood pressure \< 150, diastolic blood pressure \< 100 mm Hg) on two readings at least 3 days apart.
7. ECG abnormalities including QTc interval \> 450 ms or changes suggesting acute ischemia, \<TAB\>second or third degree heart block, left bundle branch block, atrial fibrillation, or other \<TAB\>clinically important arrhythmias. ECGs may be sent to an outside cardiologist for manual \<TAB\>reading.
8. Contraindicated medications (Self-Reported Medical History):
* Alpha-1 receptor blockers (e.g., doxazin, terazosin)
* Anti-epileptic medications (e.g., carbamazepine)
* Tricyclic antidepressants
* SSRIs
* Neuroleptics
* Quinidine
* Antifungals (e.g., ketoconazole)
* Ranolazine
* CYP3A4 inhibitors or inducers (other than methadone)
* CYP2D6 inhibitors or inducers (other than methadone)
9. Family history (Self-Reported Medical History):
* Family history of sudden death of unexplained causes
* Sudden cardiac death
* Aneurysm
* Myocardial infarction below the age 50 years
10. Psychiatric history:
A) Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires (Shipley Institute of Living scale estimated full-scale IQ less than 80)
B) History of schizophrenia or any other DSM-IV psychotic disorder (Self-Reported Medical History; Diagnostic Interview Schedule for the DSM-IV (DIS IV))
C) History of bipolar disorder (Self-Reported Medical History; DIS IV)
D) Current Major Depressive Disorder (Self-Reported Medical History; DIS IV)
E) Previous suicide attempts or ideation (Self-Reported Medical History; DIS-IV)
F) Dementia (DIS-IV; Clinical Interview; Shipley Institute of Living scale)
11. Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines (self-report; ASI; alcohol CAGE questions; and pattern of positive drug screens or BAL for alcohol)
12. Body Mass Index (BMI) over 40
13. Failure to agree to use a medically effective form of contraception while in the study (in women who are sexually active with a male partner and able to get pregnant). Acceptable forms of contraception for this study include:
* hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
* surgical sterility (tubal ligation or hysterectomy)
* IUD
* Diaphragm with spermicide
* Condom with spermicide
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00780702
Study Brief:
Protocol Section:
NCT00780702