Status:
COMPLETED
Effect of Clonidine on Responses to Imagery Scripts
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Abuse
Heroin Abuse
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Background: \- Research has shown that clonidine, a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to heroin and...
Detailed Description
Background. Stress and exposure to drug-related cues (environmental stimuli previously associated with drug availability) are considered factors that increase the risk of relapse to heroin and/or coca...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age between 18 and 55;
- 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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- Hypersensitivity to clonidine or any component of the formulation
- Schizophrenia or any other DSM-IV psychotic disorder; history of anxiety disorder, panic disorder, bipolar disorder; current Major Depressive Disorder
- 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
- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires
- Pregnancy or breast feeding
- Severely impaired hepatic function
- Severely impaired renal function, with CLcr \< 10 ml/minute
- Medical conditions that contraindicate or that could complicate clonidine administration:
- hypotension (SBP \<95 or DBP \< 40 mm Hg) over several readings
- hypertension(SBP \>160 mm Hg, DBP \>95 mm Hg) over several readings
- orthostatic hypotension over several readings or as a consequence of any underlying medical disorder (e.g., autonomic insufficiency)
- bradycardia (heart rate \< 50 bpm) over several readings
- cerebrovascular disease or any history of CVA or transient ischemic attack (TIA)
- documented coronary disease
- serious arrhythmia or conduction defect (e.g., second or third degree heart block, atrial fibrillation)
- sinus node dysfunction, severe bradycardia or symptomatic bradycardia
- congestive heart failure
- 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
- 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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- Hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
- Surgical sterility (tubal ligation or hysterectomy)
- IUD
- Diaphragm with spermicide
- Condom with spermicide
- Women who do not agree to use these medically effective forms of contraception while in the study will be excluded.
Exclusion
Key Trial Info
Start Date :
June 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00318760
Start Date
June 14 2005
End Date
August 7 2013
Last Update
April 5 2018
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224