Evidence map›Paper›PMID 26932737›Full record

ArticlePsychopharmacology2016

Safety and tolerability of intranasal cocaine during phendimetrazine maintenance.

William W Stoops, Justin C Strickland, Lon R Hays, Abner O Rayapati, Joshua A Lile, Craig R Rush

Abstract read
In one paragraph

Article in Psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 27% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Article
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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

6 authors at 1 institution in 1 country.

William W StoopsDepartment of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Room 140, Lexington, KY, 40536-0086, USA. william.stoops@uky.edu.
Justin C StricklandDepartment of Psychology, University of Kentucky College of Arts and Sciences, Kastle Hall, Lexington, KY, 40506-0044, USA.
Lon R HaysDepartment of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY, 40509-1810, USA.
Abner O RayapatiDepartment of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY, 40509-1810, USA.
Joshua A LileDepartment of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Room 140, Lexington, KY, 40536-0086, USA.
Craig R RushDepartment of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Room 140, Lexington, KY, 40536-0086, USA.
University of Kentucky · US

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR000117 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$13.3M
Selective Monoamine Release as a Treatment for Cocaine Use DisordersR01DA036553 · NIDA · UNIVERSITY OF KENTUCKY · PI STOOPS, WILLIAM WALTON · 2014 to 2017
$1.6M
NCATS NIH HHS UL1 TR000117NIDA NIH HHS R01 DA036553
6 · The paper itself

Abstract

rationalePhendimetrazine appears to have limited abuse potential and reduces cocaine self-administration in preclinical studies. No human studies have evaluated the safety and tolerability of cocaine in combination with phendimetrazine, which is a necessary next step in evaluating the efficacy of phendimetrazine for treating cocaine use disorder.

objectivesThis study determined the safety and tolerability of acute cocaine doses during chronic phendimetrazine treatment.

methodsTen subjects completed this within-subject, placebo-controlled, inpatient study. Subjects were maintained on ascending oral phendimetrazine doses (0, 70, 140, and 210 mg/day). After at least seven maintenance days at each dose, subjects received ascending doses of intranasal cocaine (0, 10, 20, 40, and 80 mg), separated by 90 min, within one session.

resultsCocaine produced prototypical cardiovascular and subject-rated effects (e.g., increased blood pressure and ratings of like drug). The cardiovascular effects of cocaine alone were not clinically significant for an acute drug response (e.g., average heart rate did not approach tachycardia, 100 beats/min). Phendimetrazine enhanced peak heart rate following placebo and low cocaine doses, but these effects were also not clinically significant. Phendimetrazine was otherwise devoid of effects alone and did not alter the subject-rated effects of cocaine or hypothetical demand for cocaine on a purchase task.

conclusionsCocaine was safe and well tolerated during maintenance on a threefold range of phendimetrazine doses. Given this safety profile, the reduced abuse potential of phendimetrazine and promising preclinical research, future human laboratory studies, and possibly clinical trials should evaluate the efficacy of phendimetrazine for reducing cocaine use.

Indexed as

Administration, IntranasalAdultCentral Nervous System StimulantsCocaineCocaine-Related DisordersDose-Response Relationship, DrugFemaleHemodynamicsHumansMaleMiddle AgedMorpholinesSelf AdministrationCentral Nervous System StimulantsCocaineMorpholinesphendimetrazineCocaineHumansPharmacotherapyPhendimetrazinePhysiological effects

Identifiers

PMID26932737
PMCPMC4864128
OpenAlexW2291509370

What OpenQuestion holds

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Registered trials

None linked

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.