Abuse liability assessment of sibutramine, a novel weight control agent.
BACKGROUND
Sibutramine (Meridia) is a serotonin and norepinephrine reuptake inhibitor marketed for weight control. Previous studies demonstrated low abuse potential for 20 and 30 mg sibutramine (doses near the therapeutic range); however, no data existed on supratherapeutic doses. This study, therefore, examined 25 and 75 mg sibutramine in humans compared to d-amphetamine (20 mg) as a positive control and placebo as a negative control.


OBJECTIVE
The study examined the acute subjective, reinforcing, and physiological effects of sibutramine to assess its abuse liability.


METHODS
Twelve polydrug abusers with no history of drug dependence participated in this double-blind, inpatient/outpatient study. Volunteers participated in four drug sessions, in which they completed subjective effects scales including the Profile of Mood States (POMS), Visual Analog Scales (VAS), and the Addiction Research Center Inventory (ARCI). The Multiple Choice Procedure (MCP) was used to evaluate reinforcing efficacy.


RESULTS
Sibutramine 25 mg produced subjective effects that were indistinguishable from placebo. Sibutramine 75 mg produced significant unpleasant effects, such as Anxiety, Confusion, and decreased Vigor. On the MCP, volunteers chose to give up an average of $4.04 from their study pay rather than receive the higher dose of sibutramine again. In contrast, d-amphetamine 20 mg produced positive mood changes and was well liked.


CONCLUSIONS
These data indicate sibutramine lacks amphetamine-type abuse liability when administered acutely.
Schuh
L M
LM
Department of Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, MI 48207, USA. lschuh@med.wayne.edu
Schuster
C R
CR
Hopper
J A
JA
Mendel
C M
CM
D000328:Adult; D000339:Affect / Q000187:drug effects; D001067:Appetite Depressants; D001794:Blood Pressure / Q000187:drug effects; D003503:Cyclobutanes; D003913:Dextroamphetamine; D004311:Double-Blind Method; D005059:Euphoria / Q000187:drug effects; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D019966:Substance-Related Disorders / Q000523:psychology*; D011795:Surveys and Questionnaires
D001067:Appetite Depressants; D003503:Cyclobutanes; D003913:Dextroamphetamine; C058254:sibutramine