PMID- 12759199
OWN - NLM
STAT- MEDLINE
DCOM- 20040204
LR  - 20190906
IS  - 0376-8716 (Print)
IS  - 0376-8716 (Linking)
VI  - 70
IP  - 3 Suppl
DP  - 2003 Jun 5
TI  - Assessing abuse liability in clinical trials.
PG  - S87-95
AB  - In this article, the use of data collected in registration-focused clinical 
      trials to provide information concerning abuse liability of compounds under 
      development is discussed. Registration-focused trials are limited by the small 
      and select sample chosen for study participation and design constraints. However, 
      most compounds under development are first administered to humans during the 
      conduct of registration-focused trials, so this presents an opportunity to 
      collect potentially important information about the effects of drugs in humans. 
      At present, information concerning subjective effects and symptoms associated 
      with drug discontinuation are not collected systematically. Reports are generally 
      considered as adverse events (AEs) and are recorded on the case report forms 
      (CRFs) in the investigators own language. There is generally no rating of drug 
      "liking". The authors suggest strategies that could be implemented in 
      registration-focused clinical trials to improve the information gathered with 
      regard to subjective effects, abuse liability and discontinuation-emergent 
      symptoms. Importantly, there remains much groundwork to be done in developing and 
      validating appropriate assessment instruments and determining "threshold" levels 
      for concern. Under the best of circumstances, registration-focused clinical 
      trials have limited potential to detect abuse liability because of the small 
      number of patients seen and the exclusion of many subjects who might be 
      particularly vulnerable to the abuse of marketed compounds (i.e. individuals with 
      substance use disorders). In cases where there are reasons to suspect that a drug 
      under development has abuse potential, systematic exploration with a series of 
      studies specifically designed to assess abuse potential must be conducted.
FAU - Brady, Kathleen T
AU  - Brady KT
AD  - Department of Psychiatry, Ralph H. Johnson Medical Center, Medical University of 
      South Carolina (MUSC/CTN), 109 Bee Street, Charleston, SC 29401, USA. 
      bradyk@musc.edu
FAU - Lydiard, R Bruce
AU  - Lydiard RB
FAU - Brady, Joseph V
AU  - Brady JV
LA  - eng
GR  - K24 DA 00435/DA/NIDA NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PT  - Review
PL  - Ireland
TA  - Drug Alcohol Depend
JT  - Drug and alcohol dependence
JID - 7513587
RN  - 0 (Psychotropic Drugs)
SB  - IM
MH  - Clinical Trials as Topic/*methods
MH  - Drug and Narcotic Control
MH  - Humans
MH  - *Psychotropic Drugs
MH  - Registries
MH  - Research Design
MH  - *Risk Assessment
MH  - Substance-Related Disorders/*etiology
RF  - 18
EDAT- 2003/05/22 05:00
MHDA- 2004/02/05 05:00
CRDT- 2003/05/22 05:00
PHST- 2003/05/22 05:00 [pubmed]
PHST- 2004/02/05 05:00 [medline]
PHST- 2003/05/22 05:00 [entrez]
AID - S0376871603001017 [pii]
AID - 10.1016/s0376-8716(03)00101-7 [doi]
PST - ppublish
SO  - Drug Alcohol Depend. 2003 Jun 5;70(3 Suppl):S87-95. doi: 
      10.1016/s0376-8716(03)00101-7.