Baclofen as relapse prevention in the treatment of Gamma-hydroxybutyrate (GHB) dependence: an open label study.

Completed

• Conditions: Dependence and craving; Addiction and relapse

• Registration Number: NL-OMON39314
• Lead Sponsor: Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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.
- History or presence of a current psychiatric disorder, including any mood disorder (bipolar disorder or major depressive disorder), any psychotic disorder (including schizophrenia), and/or suicidal ideations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Substance use levels, as indexed by the total number of abstinent days, the<br /><br>duration of continued abstinence after detoxification and level of substance<br /><br>use over a period of 3 months (Timeline Followback). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>These are:<br /><br>- Craving levels, as indexed by self report using a visual analogue scale (VAS)<br /><br>and the Desire for Drugs Questionnaire (DDQ) adapted to GHB.<br /><br>- Psychiatric symptom levels (as indexed by self report Depression, Anxiety and<br /><br>Stress Scale; DASS) and Quality of life (as measured with EQoL-5D). </p><br>