Baclofen as treatment for relapse in GHB abuse
- Conditions
- Relapse prevention in GHB
- Registration Number
- NL-OMON24379
- Lead Sponsor
- ijmegen Institute for Scientist-Practitioners in Addiction (NISPA)/ Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
GHB dependence is the primary diagnosis, according to the DSM-IV criteria. Patients are between 18-65 years old and should be able to read and speak Dutch sufficiently
Patients with any current physical or psychiatric safety concerns are excluded.
Exclusion criteria are:
- Presence of a somatic safety concerns. These include liver cirrhosis and impaired renal function (as indicated by aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) level >3 times the upper limit of normal (ULN); bilirubin > ULN; serum creatinine > ULN) , unstable hypertension, diabetes mellitus, and seizure disorder, including well controlled cases, currently taking anticonvulsants, insulin, or oral hypoglycemic and pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Substance use levels, as indexed by the total number of abstinent days, the duration of continued abstinence after detoxification and level of substance use over a period of 3 months (Timeline Followback).
- Secondary Outcome Measures
Name Time Method These are:<br /><br>- Craving levels, as indexed by self report using a visual analogue scale (VAS) and the Desire for Drugs Questionnaire (DDQ) adapted to GHB. <br /><br>- Psychiatric symptom levels (as indexed by self report Depression, Anxiety and Stress Scale; DASS) and Quality of life (as measured with EQoL-5D). <br>