GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1

• Status: Withdrawn
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Lorazepam; Pentobarbital

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for GHB dependence

• Self-reported as GHB dependent with current daily use of GHB

• Use of GHB for at least 20 consecutive days prior to enrollment

• Desire to stop GHB use

• Availability of a friend or family member to act as a collateral informant

• Speaks and understands English

Exclusion Criteria:

• Females who are pregnant, breastfeeding, or do not agree to use adequate forms of contraception

• History of seizures

• A baseline EEG of clinical concern that requires inpatient ICU detoxification

• Any anticonvulsant therapy during the 3 years prior to enrollment

• Pancreatic disease, such as insulin-dependent diabetes

• Liver disease that requires medication or medical treatment

• Gastrointestinal or kidney disease that might significantly impair absorption, metabolism, or excretion of study drug, or might require medication or medical treatment

• Asthma, hives, angioedema, or similar condition

• Acute intermittent porphyria or porphyria variegata

• Neurological or psychiatric disorders, including psychosis, bipolar disorder, or other disorders that require treatment or might make study compliance difficult (assessed by the Structured Clinical Interview for DSM-IV-TR)

• Positive tuberculosis (PPD) skin test with a clinical history and chest X-ray indicative of active tuberculosis (individuals with a positive PPD test and a negative chest X-ray, who are not symptomatic for tuberculosis and do not require antituberculosis therapy, will be eligible to participate)

• Clinically significant abnormal baseline EKG

• Requirement for any of the following medications currently or within the 4 weeks prior to enrollment: psychotropics (including sedatives/hypnotics, antidepressants, neuroleptics), prescription analgesics, anticonvulsants, antihypertensives, antiarrhythmics, or antiretroviral medications

• Nicotine dependent participants will be given nicotine patch therapy for the duration of the study; participants who refuse nicotine patch therapy will continue in the study as determined by the hospital smoking and standard of care regulations

• Meets DSM-IV criteria for dependence on any psychoactive substance other than GHB, caffeine, or nicotine

• Symptomatic HIV infection

• Alcohol breath test greater than .05 ppm at time of hospital admission