Evidence map›Paper›PMID 24424425›Full record

Trial reportDrug and alcohol dependence2014

A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone.

Joy M Schmitz, Charles E Green, Angela L Stotts, Jan A Lindsay, Nuvan S Rathnayaka, John Grabowski, F Gerard Moeller

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Drug and alcohol dependence, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00218023 (Screening Medications for Cocaine Cessation and Relapse Prevention), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
5.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00218023 phase2completednot on this map

Screening Medications for Cocaine Cessation and Relapse Prevention

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2006 to 2012Enrolled101ConditionsCocaine Abuse, Cocaine-Related DisordersArmsModafinil, Levodopa/Carbidopa, Naltrexone HCl, Placebo, Motivational Interviewing (MI)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Dopamine agonists for the treatment of cocaine dependence.The Cochrane database of systematic reviews · 2015
    Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Continuing Increase in Stimulant Dependence - Time to Implement Medical Treatment.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2022
    Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Joy M SchmitzDepartment of Psychiatry and Behavioral Sciences, University of Texas, Houston, United States. Electronic address: Joy.M.Schmitz@uth.tmc.edu.
Charles E GreenCenter for Clinical Research & Evidence-Based Medicine, University of Texas, Houston, United States.
Angela L StottsDepartment of Family and Community Medicine, University of Texas, Houston, United States.
Jan A LindsayMenninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, United States; Veterans Affairs South Central Mental Illness Research, Education, and Clinical Center, United States; Houston VA Health Services Research & Development Center of Excellence, United States.
Nuvan S RathnayakaDepartment of Psychiatry and Behavioral Sciences, University of Texas, Houston, United States.
John GrabowskiDepartment of Psychiatry, Medical School, University of Minnesota, United States.
F Gerard MoellerDepartment of Psychiatry, Virginia Commonwealth University, United States.
University of Houston · USCenter for Clinical Research (United States) · USMental Illness Research, Education and Clinical Centers · USUniversity of Minnesota Medical Center · USVirginia Commonwealth University · US

Funding

Translational MR Imaging in Cocaine Pharmacotherapy DevelopmentP50DA009262 · NIDA · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI GREEN, CHARLES EDWARD · 1994 to 2014
$26.9M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371NIDA NIH HHS P50 DA009262NIDA NIH HHS P50-DA-9262
6 · The paper itself

Abstract

backgroundCocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels, obscuring possible medication efficacy. Testing the feasibility of using a prerandomization, abstinence-induction protocol, we screened three candidate medications to explore treatment response in patients who did, or did not, achieve abstinence during an extended baseline phase.

methodEligible treatment-seeking, cocaine-dependent subjects entered a 4-week baseline period (Phase I) with high-value abstinence contingent vouchers and two motivational interviewing sessions, followed by a 12-week medication trial (Phase II) with random assignment stratified on Phase I abstinence status to (1) modafinil (400mg/d), (2) levodopa/carbidopa (800/200mg/d), (3) naltrexone (50mg/d), or (4) placebo. Treatment consisted of thrice-weekly clinic visits for urine benzoylecgonine testing and weekly cognitive behavioral therapy with contingency management targeting medication compliance.

resultsOf the 118 subjects enrolled, 81 (80%) completed Phase I, with 33 (41%) achieving abstinence, defined a priori as 6 consecutive cocaine-negative urines. Tests of the interaction of each medication (active versus placebo) by baseline status (abstinent versus nonabstinent) permitted moderator effect analysis. Overall, baseline abstinence predicted better outcome. Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status, with both medications producing benefit in nonabstinent but not baseline-abstinent subjects. There was no evidence of a moderator effect for modafinil.

conclusionsThe two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications.

Indexed as

AdolescentAdultBenzhydryl CompoundsCarbidopaCentral Nervous System StimulantsCocaine-Related DisordersCognitive Behavioral TherapyData Interpretation, StatisticalDiagnostic and Statistical Manual of Mental DisordersDopamine AgentsFemaleHumansLevodopaMaleMiddle AgedModafinilBenzhydryl CompoundsCarbidopaCentral Nervous System StimulantsDopamine AgentsLevodopaModafinilNaltrexoneNarcotic AntagonistsCocaine cessationContingency managementLevodopaModafinilNaltrexoneRelapse prevention

Identifiers

PMID24424425
PMCPMC3944935
OpenAlexW1997504898

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.