The effect of baclofen on food craving scores and binge eating episodes in obese subjects

At the moment, medicamental treatment options for obesity are limited.
Pharmacotherapy can be chosen when there is less than 5% weight reduction after
one year of lifestyle changing. However, the effectiveness of these medication,
like orlistat and sibutramine, is moderate with an overall weight reduction of
about 5-10% of the total body weight. Besides that, these drugs have
significant side effects such as hypertension and insomnia for sibutramine and
diarrhea and flatus for orlistat. Until 2010 subtramine was marketed and
prescribed as an adjunct in the treatment of obesity along with diet and
exercise. Since sibutramine has been associated with increased cardiovascular
events and strokes the drug is withdrawn from the market.

The effects of baclofen on addiction is still under investigation. The
gamma-aminobutyric acid B (GABA-B) agonist baclofen is registered for the
treatment of spasms of skeletal muscles, muscle clonus, rigidity and pain
caused by disorders such as multiple sclerosis or cerebral palsy. It is also
injected intrathecal for the management of severe spasticity. Baclofen was
approved by the FDA in November 1977.
Baclofen has already proven effective in substance abuse. In animal models of
repeated drug abuse, baclofen reduces self-administration of a variety of drug
reinforcers, including cocaine, d-amphetamine, metamphetamine, ethanol,
nicotine, and heroin. Clinical trials of baclofen in the treatment of alcohol,
cocaine and opiate use disorders have yielded encouraging results. In a
randomized, double-blind placebo-controlled trial of baclofen in alcohol
dependent patients, baclofen was effective in inducing abstinence from alcohol
as well as reducing alcohol intake, alcohol craving, and state anxiety.
Baclofen may be equally efficacious in attenuating binge eating. It has been
shown that baclofen reduced fat intake in rats under binge-type condition. In a
human non-placebo controlled trial of 7 patients with binge eating disorder
baclofen reduced the binge eating episodes with 50% in 5 patients.

Although results of these studies are promising, the effect of baclofen on food
craving and weight reduction in obese subjects has insufficiently been studied
in randomized trials.

To establish the efficacy of 60 mg baclofen compared to placebo in inducing a
decrease in food craving, as assessed by a food craving questionnaires
(G-FCQ-T) over 6 months in obese subjects.

Clinical randomised controlled trial

Baclofen will be started with an initial doses of 5 mg a day. Every day 5 mg
baclofen extra will be added tot the dosage with a final maximum dosage of 20
mg three times a day.

The use of baclofen may cause sife effects. De side effects will be minimal and
harmless. Patients will be contacted weekly by telephone to inform about the
side effects of baclofen.