Evidence map›Paper›PMID 25887096›Full record

Trial reportJAMA psychiatry2015

Extended-Release Mixed Amphetamine Salts vs Placebo for Comorbid Adult Attention-Deficit/Hyperactivity Disorder and Cocaine Use Disorder: A Randomized Clinical Trial.

Frances R Levin, John J Mariani, Sheila Specker, Marc Mooney, Amy Mahony, Daniel J Brooks, David Babb, Yun Bai, Lynn E Eberly, Edward V Nunes and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00553319 (A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts), which is not on this map. Cited by 79 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 7 pooled it
9.9field-weighted citation impact, top 1% 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.

NCT00553319 phase2 / phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence

TypeinterventionalSponsorNew York State Psychiatric InstituteRan2007 to 2013Enrolled139ConditionsAdult Attention Deficit Hyperactivity Disorder, Cocaine DependenceArmsPlacebo, Adderall-XR
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 7 syntheses or guidelines pooled it, 170 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Guideline
  7. Pooled it
  8. Trial
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  10. Open-label pilot study of lisdexamfetamine for cocaine use disorder.The American journal of drug and alcohol abuse · 2021
    Trial
  11. Trial
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  15. Article
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  19. Article
  20. ADHD, substance use disorders and stimulant treatment: understanding the relationships.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2025
    Article

19 more citing papers are in PubMed but not listed here.

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

11 authors at 5 institutions in 1 country.

Frances R LevinDivision of Substance Abuse, New York State Psychiatric Institute, New York2Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
John J MarianiDivision of Substance Abuse, New York State Psychiatric Institute, New York2Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
Sheila SpeckerDepartment of Psychiatry, Medical School, University of Minnesota, Minneapolis.
Marc MooneyDepartment of Psychiatry, Medical School, University of Minnesota, Minneapolis.
Amy MahonyDivision of Substance Abuse, New York State Psychiatric Institute, New York.
Daniel J BrooksDivision of Substance Abuse, New York State Psychiatric Institute, New York.
David BabbDepartment of Psychiatry, Medical School, University of Minnesota, Minneapolis.
Yun BaiDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.
Lynn E EberlyDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.
Edward V NunesDivision of Substance Abuse, New York State Psychiatric Institute, New York2Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, New York.
John GrabowskiDepartment of Psychiatry, Medical School, University of Minnesota, Minneapolis.
University of Minnesota Medical Center · USNew York State Office of Alcoholism and Substance Abuse Services · USUniversity of Minnesota · USColumbia University · USNew York State Psychiatric Institute

Funding

Extended Release Mixed Amphetamine Salts for Adult ADHD and Cocaine DependenceR01DA023652 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI LEVIN, FRANCES RUDNICK · 2007 to 2010
$2.1M
Substance Abuse Treatment Development and Clinical Research MentoringK24DA029647 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2010 to 2019
$1.8M
Drug Abuse Treatment Development and Research MentoringK24DA022412 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI NUNES, EDWARD V. · 2007 to 2016
$1.7M
Extended-Release Mixed Amphetamine Salts for Adults ADHD and Cocaine DependenceR01DA023651 · NIDA · UNIVERSITY OF MINNESOTA · PI GRABOWSKI, JOHN G · 2008 to 2012
$1.6M
NIDA NIH HHS K24 DA022412NIDA NIH HHS K24 DA029647NIDA NIH HHS R01 DA023651NIDA NIH HHS R01DA 023651NIDA NIH HHS R01 DA023652NIDA NIH HHS R01DA 023652PHS HHS KO2000465
6 · The paper itself

Abstract

importanceAdult attention-deficit/hyperactivity disorder (ADHD) is prevalent but often unrecognized, in part because it tends to co-occur with other disorders such as substance use disorders. Cocaine use disorder is one such disorder with high co-occurrence of ADHD.

objectiveTo examine whether treatment of co-occurring ADHD and cocaine use disorder with extended-release mixed amphetamine salts is effective at both improving ADHD symptoms and reducing cocaine use. DESIGN, SETTING, AND

participantsThirteen-week, randomized, double-blind, 3-arm, placebo-controlled trial of participants meeting DSM-IV-TR criteria for both ADHD and cocaine use disorder conducted between December 1, 2007, and April 15, 2013, at 2 academic health center substance abuse treatment research sites. One hundred twenty-six adults diagnosed as having comorbid ADHD and cocaine use disorder were randomized to extended-release mixed amphetamine salts or placebo. Analysis was by intent-to-treat population.

interventionsParticipants received extended-release mixed amphetamine salts (60 or 80 mg) or placebo daily for 13 weeks and participated in weekly individual cognitive behavioral therapy. MAIN OUTCOMES AND MEASURES: For ADHD, percentage of participants achieving at least a 30% reduction in ADHD symptom severity, measured by the Adult ADHD Investigator Symptom Rating Scale; for cocaine use, cocaine-negative weeks (by self-report of no cocaine use and weekly benzoylecgonine urine screens) during maintenance medication (weeks 2-13) and percentage of participants achieving abstinence for the last 3 weeks.

resultsMore patients achieved at least a 30% reduction in ADHD symptom severity in the medication groups (60 mg: 30 of 40 participants [75.0%]; odds ratio [OR] = 5.23; 95% CI, 1.98-13.85; P < .001; and 80 mg: 25 of 43 participants [58.1%]; OR = 2.27; 95% CI, 0.94-5.49; P = .07) compared with placebo (17 of 43 participants [39.5%]). The odds of a cocaine-negative week were higher in the 80-mg group (OR = 5.46; 95% CI, 2.25-13.27; P < .001) and 60-mg group (OR = 2.92; 95% CI, 1.15-7.42; P = .02) compared with placebo. Rates of continuous abstinence in the last 3 weeks were greater for the medication groups than the placebo group: 30.2% for the 80-mg group (OR = 11.87; 95% CI, 2.25-62.62; P = .004) and 17.5% for the 60-mg group (OR = 5.85; 95% CI, 1.04-33.04; P = .04) vs 7.0% for placebo. CONCLUSIONS AND RELEVANCE: Extended-release mixed amphetamine salts in robust doses along with cognitive behavioral therapy are effective for treatment of co-occurring ADHD and cocaine use disorder, both improving ADHD symptoms and reducing cocaine use. The data suggest the importance of screening and treatment of ADHD in adults presenting with cocaine use disorder.

trial registrationclinicaltrials.gov Identifier:NCT00553319.

Indexed as

AdolescentAdultAmphetaminesAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsCocaine-Related DisordersCognitive Behavioral TherapyCombined Modality TherapyDelayed-Action PreparationsDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient ComplianceTreatment OutcomeAmphetaminesCentral Nervous System StimulantsDelayed-Action Preparations

Identifiers

PMID25887096
PMCPMC4456227
OpenAlexW2010098953

What OpenQuestion holds

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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.