Baclofen as relapse prevention in the treatment of Gamma- Hydroxybutyrate (GHB) dependence: an open label study.
BACKGROUND
GHB dependence is a growing health problem in several western countries, especially the Netherlands. Attempts to stop using GHB are often followed by relapse shortly after successful detoxification. Craving for GHB use and co-morbid psychiatric symptom levels are thought to be the major factors contributing to the high relapse rates. Given its pharmacological profile, baclofen might prove an effective anti-craving agent for patients with GHB dependence. The aim of the current study is to assess the potential of baclofen as an anti-craving agent relapse prevention intervention in GHB dependent patients.


METHODS
In an open label non-randomized trial treatment with baclofen to a maximum of 60 mg/day will be compared with treatment as usual (TAU) in recently detoxified GHB dependent patients (n = 80). The primary outcome measure will be the level of GHB use. Secondary outcome measures are craving levels, psychiatric symptom levels and quality of life. Questionnaires will be administered during 12 weeks of baclofen treatment and at follow-up (six months after the start of treatment).


CONCLUSIONS
It is hypothesized that baclofen treatment compared to TAU will be associated with significantly reduced GHB use. In addition, we hypothesize that baclofen treatment will be associated with decreased craving and anxiety levels, and higher quality of life. If results are in line with our hypotheses, further studies on the efficacy of baclofen using placebo controlled designs and long term follow-up are warranted.


BACKGROUND
The Netherlands Trial Register with number NTR4528 . Registered 19 April 2014.
Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Hogedwarsstraat 3, PO Box 243, Vught, 5260 AE, the Netherlands. rama.kamal@novadic-kentron.nl.|Novadic-Kentron Addiction Care network, Vught, the Netherlands. rama.kamal@novadic-kentron.nl.
Rama M
RM
Kamal
Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Hogedwarsstraat 3, PO Box 243, Vught, 5260 AE, the Netherlands. arnt.schellekens@gmail.com.
Arnt
A
Schellekens
Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Hogedwarsstraat 3, PO Box 243, Vught, 5260 AE, the Netherlands. nispa.dejong@gmail.com.
Cornelis A J
CA
De Jong
Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Hogedwarsstraat 3, PO Box 243, Vught, 5260 AE, the Netherlands. boukje.dijkstra@novadic-kentron.nl.
Boukje A G
BA
Dijkstra
D000328:Adult; D001418:Baclofen / Q000627:therapeutic use*; D002985:Clinical Protocols; D066249:Craving / Q000187:drug effects; D005260:Female; D018755:GABA Agonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D011788:Quality of Life; D012008:Recurrence; D055502:Secondary Prevention; D012978:Sodium Oxybate / Q000009:adverse effects*; D019966:Substance-Related Disorders / Q000188:drug therapy* / Q000517:prevention & control; D055815:Young Adult
D018755:GABA Agonists; D012978:Sodium Oxybate; D001418:Baclofen