Relapse prevention in GHB
Conditions
Interventions
Patients will receive either baclofen as medication plus TAU or TAU alone. Baclofen will be uploaded over a 2 week period to a maximum of 45-60 mg. Baclofen will be administrated 3 times daily for 12
Sponsors
Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA)/ Mental Health Care and Addiction Services (GGZ Nederland)/National program “Scoring Results
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| These are: - Craving levels, as indexed by self report using a visual analogue scale (VAS) and the Desire for Drugs Questionnaire (DDQ) adapted to GHB. - Psychiatric symptom levels (as indexed by self report Depression, Anxiety and Stress Scale; DASS) and Quality of life (as measured with EQoL-5D). | — |
Contacts
Public ContactBoukje Dijkstra
Toernooiveld 5
Outcome results
None listed