Determining the primary endpoint for a stimulant abuse trial

Lessons learned from STRIDE (CTN 0037)

Madhukar H. Trivedi, Tracy L. Greer, Jennifer Sharpe Potter, Bruce D. Grannemann, Edward V. Nunes, Chad Rethorst, Diane Warden, Kolette M. Ring, Eugene Somoza

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. Objectives: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. Methods: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. Conclusion: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. Scientific Significance: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.

Original languageEnglish (US)
Pages (from-to)339-349
Number of pages11
JournalAmerican Journal of Drug and Alcohol Abuse
Volume37
Issue number5
DOIs
StatePublished - Sep 2011

Fingerprint

Substance-Related Disorders
Population Characteristics
Pharmaceutical Preparations
Consensus
Clinical Trials
Urine
Interviews
trans-crotonin
Surveys and Questionnaires
N-nitrosoiminodiacetic acid

Keywords

  • Cocaine abuse
  • Endpoint
  • Exercise
  • Measurement
  • Stimulant abuse

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Determining the primary endpoint for a stimulant abuse trial : Lessons learned from STRIDE (CTN 0037). / Trivedi, Madhukar H.; Greer, Tracy L.; Potter, Jennifer Sharpe; Grannemann, Bruce D.; Nunes, Edward V.; Rethorst, Chad; Warden, Diane; Ring, Kolette M.; Somoza, Eugene.

In: American Journal of Drug and Alcohol Abuse, Vol. 37, No. 5, 09.2011, p. 339-349.

Research output: Contribution to journalArticle

Trivedi, Madhukar H. ; Greer, Tracy L. ; Potter, Jennifer Sharpe ; Grannemann, Bruce D. ; Nunes, Edward V. ; Rethorst, Chad ; Warden, Diane ; Ring, Kolette M. ; Somoza, Eugene. / Determining the primary endpoint for a stimulant abuse trial : Lessons learned from STRIDE (CTN 0037). In: American Journal of Drug and Alcohol Abuse. 2011 ; Vol. 37, No. 5. pp. 339-349.
@article{20848dcf264d4560baf592e59b06c922,
title = "Determining the primary endpoint for a stimulant abuse trial: Lessons learned from STRIDE (CTN 0037)",
abstract = "Background: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. Objectives: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. Methods: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. Conclusion: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. Scientific Significance: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.",
keywords = "Cocaine abuse, Endpoint, Exercise, Measurement, Stimulant abuse",
author = "Trivedi, {Madhukar H.} and Greer, {Tracy L.} and Potter, {Jennifer Sharpe} and Grannemann, {Bruce D.} and Nunes, {Edward V.} and Chad Rethorst and Diane Warden and Ring, {Kolette M.} and Eugene Somoza",
year = "2011",
month = "9",
doi = "10.3109/00952990.2011.598589",
language = "English (US)",
volume = "37",
pages = "339--349",
journal = "American Journal of Drug and Alcohol Abuse",
issn = "0095-2990",
publisher = "Informa Healthcare",
number = "5",

}

TY - JOUR

T1 - Determining the primary endpoint for a stimulant abuse trial

T2 - Lessons learned from STRIDE (CTN 0037)

AU - Trivedi, Madhukar H.

AU - Greer, Tracy L.

AU - Potter, Jennifer Sharpe

AU - Grannemann, Bruce D.

AU - Nunes, Edward V.

AU - Rethorst, Chad

AU - Warden, Diane

AU - Ring, Kolette M.

AU - Somoza, Eugene

PY - 2011/9

Y1 - 2011/9

N2 - Background: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. Objectives: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. Methods: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. Conclusion: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. Scientific Significance: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.

AB - Background: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. Objectives: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. Methods: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. Conclusion: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. Scientific Significance: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.

KW - Cocaine abuse

KW - Endpoint

KW - Exercise

KW - Measurement

KW - Stimulant abuse

UR - http://www.scopus.com/inward/record.url?scp=80052235784&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80052235784&partnerID=8YFLogxK

U2 - 10.3109/00952990.2011.598589

DO - 10.3109/00952990.2011.598589

M3 - Article

VL - 37

SP - 339

EP - 349

JO - American Journal of Drug and Alcohol Abuse

JF - American Journal of Drug and Alcohol Abuse

SN - 0095-2990

IS - 5

ER -