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Clinical Trials/NL-OMON39314
NL-OMON39314
Completed
N/A

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

Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results0 sites100 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results
Enrollment
100
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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