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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00318760
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age between 18 and 55;
2. Evidence of current cocaine and/or heroin use (by self-report) with a minimum lifetime drug-use duration of 1 year and a minimum current drug use of once in the last 30 days;
EXCLUSION CRITERIA:
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1. Hypersensitivity to clonidine or any component of the formulation
2. Schizophrenia or any other DSM-IV psychotic disorder; history of anxiety disorder, panic disorder, bipolar disorder; current Major Depressive Disorder
3. Current physical dependence on opioids, cocaine, alcohol, benzodiazepines or other sedative-hypnotic; this is an exclusion criterion because we want to evaluate the ability of clonidine to affect stress- and cue-induced drug craving independent of its effects on drug withdrawal
4. Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires
5. Pregnancy or breast feeding
6. Severely impaired hepatic function
7. Severely impaired renal function, with CLcr \< 10 ml/minute
8. Medical conditions that contraindicate or that could complicate clonidine administration:
1. hypotension (SBP \<95 or DBP \< 40 mm Hg) over several readings
2. hypertension(SBP \>160 mm Hg, DBP \>95 mm Hg) over several readings
3. orthostatic hypotension over several readings or as a consequence of any underlying medical disorder (e.g., autonomic insufficiency)
4. bradycardia (heart rate \< 50 bpm) over several readings
5. cerebrovascular disease or any history of CVA or transient ischemic attack (TIA)
6. documented coronary disease
7. serious arrhythmia or conduction defect (e.g., second or third degree heart block, atrial fibrillation)
8. sinus node dysfunction, severe bradycardia or symptomatic bradycardia
9. congestive heart failure
9. Medications that could interact adversely with clonidine: antipsychotics; antihypertensives (e.g., beta blockers); antiepileptics; CNS depressants (e.g. barbiturates, benzodiazepines, narcotic analgesics, alcohol, or other sedatives); cyclosporine; oral hypoglycemic agents or insulin; levodopa; tricyclic antidepressants; herbals such as dong quai, ephedra, yohimbe, ginseng, valerian, St. John s wort, kava kava, gotu kola
10. Women who are able to get pregnant and are not abstinent from sexual activity must agree to use a medically effective form of contraception while in the study. Those include:
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1. Hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
2. Surgical sterility (tubal ligation or hysterectomy)
3. IUD
4. Diaphragm with spermicide
5. Condom with spermicide
Women who do not agree to use these medically effective forms of contraception while in the study will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00318760
Study Brief:
Protocol Section:
NCT00318760