title: Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials.
abstract: OBJECTIVE
  Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials.
  
  
  METHODS
  A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated.
  
  
  RESULTS
  Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials.
  
  
  CONCLUSIONS
  We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.
authors.affiliation: Alcohol and Drug Abuse Institute, University of Washington, Seattle, USA. ddonovan@u.washington.edu
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Donovan
authors.forename: George E
authors.initials: GE
authors.lastname: Bigelow
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Brigham
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Carroll
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Cohen
authors.forename: John G
authors.initials: JG
authors.lastname: Gardin
authors.forename: John A
authors.initials: JA
authors.lastname: Hamilton
authors.forename: Marilyn A
authors.initials: MA
authors.lastname: Huestis
authors.forename: John R
authors.initials: JR
authors.lastname: Hughes
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.forename: G Alan
authors.initials: GA
authors.lastname: Marlatt
authors.forename: Kenzie L
authors.initials: KL
authors.lastname: Preston
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Selzer
authors.forename: Eugene C
authors.initials: EC
authors.lastname: Somoza
authors.forename: Paul G
authors.initials: PG
authors.lastname: Wakim
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Wells
mesh_terms: D000437:Alcoholism / Q000534:rehabilitation; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods*; D032921:Consensus; D023381:Endpoint Determination; D006801:Humans; D013287:Illicit Drugs; D057566:Self Report; D015813:Substance Abuse Detection / Q000379:methods; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis; D019966:Substance-Related Disorders / Q000534:rehabilitation*; D014029:Tobacco Use Disorder / Q000534:rehabilitation; D016896:Treatment Outcome
chemical_list: D013287:Illicit Drugs