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.
Investigators
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
Similar Trials
Recruiting
N/A
Baclofen as treatment for relapse in GHB abuseNL-OMON24379ijmegen Institute for Scientist-Practitioners in Addiction (NISPA)/ Mental Health Care and Addiction Services (GGZ Nederland)/National program Scoring Results100
Completed
N/A
Baclofen for maintenance treatment of opioid dependence: A randomised double-blind placebo-controlled clinical trialISRCTN32121581Roozbeh Addiction Department (Iran)40
Completed
Phase 3
Efficacy and safety of Baclofen GRS for treatment of alcohol dependence, a 12 week studyHealth Condition 1: F102- Alcohol dependenceHealth Condition 2: null- diagnosis of alcohol dependenceCTRI/2011/11/002154Sun Pharma Advanced Research Company Ltd195
Active, Not Recruiting
N/A
A placebo controlled trial with Baclofen for the treatment of GERD patients with incomplete PPI responseGastroesophageal reflux diseaseEUCTR2009-017351-96-BEZleuven
Active, Not Recruiting
Phase 1
Study investigating the effect of baclofen in patients with postprandial regurgitation or belchingRumination syndrome and supragastric belchingMedDRA version: 14.0Level: LLTClassification code 10039292Term: Rumination disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.0Level: LLTClassification code 10004222Term: BelchingSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2011-002745-35-BEZLeuven20