TCET AS AN AID TO OPOIATE DRUG WITHDRAWAL

PRELIMINARY EVIDENCE INDICATES THAT A PATENTED FORM OF LOW CURRENT TRANS-CRANIAL ELECTROSTIMULATION THERAPY (TCET) ATTENUATES ACUTE OPIATE ABSTINENCE SYNDROME IN MORPHINE ADDICTED RATS. THIS STUDY WILL EXAMINE THE POSSIBILITY THAT TCET ATTENUATES ACUTE AND/OR SECONDARY OPIATE ABSTINENCE SYNDROME IN REHABILITATING DRUG ABUSERS. IN PHASE I OF THE GRANT, DETAILED PROTOCOLS AND APPROVALS WILL BE SOUGHT FOR THE PHASE II ACUTE AND SECONDARY STUDIES. IN THE ACUTE PHASE II STUDY, TCET WILL BE COMPARED WITH PLACEBO AND SUB-MAINTENANCE DOSES OF MORPHINE IN DOUBLE-BLIND, DOUBLE DUMMY IN-PATIENT DESIGN FOLLOWING A STANDARD 24 HOUR SUBSTITUTION PROTOCOL. SUBJECTIVE AND OBJECTIVE MEASURES OF SUBJECT DISCOMFORT WILL BE MONITORED AS INDICATORS OF EFFICACY. IN THE SECONDARY PHASE II STUDY, TCET WILL BE STUDIES IN AN OUT-PATIENT DESIGN. IF TCET IS PROVED EFFECTIVE IN ASSISTING WITHDRAWAL FROM OPIATE DRUGS, SPECIAL BENEFITS INCLUDE LACK OF SIDE EFFECTS WITH PHARMACOLOGICAL INTERVENTIONS, AND SUITABILITY FOR TREATING PREGNANT ADDICTS. PRELIMINARY EVIDENCE INDICATES THAT A PATENTED FORM OF LOW CURRENT TRANS-CRANIAL ELECTROSTIMULATION THERAPY (TCET) ATTENUATES ACUTE OPIATE ABSTINENCE SYNDROME IN MORPHINE ADDICTED RATS. THIS STUDY WILL EXAMINE THE POSSIBILITY THAT TCET ATTENUATES ACUTE AND/OR SECONDARY OPIATE ABSTINENCE SYNDROME IN REHABILITATING DRUG ABUSERS. IN PHASE I OF THE GRANT, DETAILED PROTOCOLS AND APPROVALS WILL BE SOUGHT FOR THE PHASE II ACUTE AND SECONDARY STUDIES. IN THE ACUTE PHASE II STUDY, TCET WILL BE COMPARED WITH PLACEBO AND SUB-MAINTENANCE DOSES OF MORPHINE IN DOUBLE-BLIND, DOUBLE DUMMY IN-PATIENT DESIGN FOLLOWING A STANDARD 24 HOUR SUBSTITUTION PROTOCOL. SUBJECTIVE AND OBJECTIVE MEASURES OF SUBJECT DISCOMFORT WILL BE MONITORED AS INDICATORS OF EFFICACY. IN THE SECONDARY PHASE II STUDY, TCET WILL BE STUDIES IN AN OUT-PATIENT DESIGN. IF TCET IS PROVED EFFECTIVE IN ASSISTING WITHDRAWAL FROM OPIATE DRUGS, SPECIAL BENEFITS INCLUDE LACK OF SIDE EFFECTS WITH PHARMACOLOGICAL INTERVENTIONS, AND SUITABILITY FOR TREATING PREGNANT ADDICTS.