Evidence map›Paper›PMID 27363313›Full record

Trial reportJournal of clinical pharmacology2017

Pharmacokinetics and Safety Assessment of l-Tetrahydropalmatine in Cocaine Users: A Randomized, Double-Blind, Placebo-Controlled Study.

Hazem E Hassan, Deanna Kelly, Moshe Honick, Sagar Shukla, Ahmed Ibrahim, David A Gorelick, Matthew Glassman, Robert P McMahon, Heidi J Wehring, Ann Marie Kearns and 4 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 24% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Natural Product-Inspired Dopamine Receptor Ligands.Journal of medicinal chemistry · 2024
    Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. 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

14 authors at 2 institutions in 2 countries.

Hazem E HassanDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
Deanna KellyMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Moshe HonickDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
Sagar ShuklaDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
Ahmed IbrahimDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
David A GorelickMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Matthew GlassmanMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Robert P McMahonMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Heidi J WehringMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Ann Marie KearnsMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Stephanie FeldmanMaryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Mingming YuDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
Ken BauerLake Erie College of Osteopathic Medicine, Bradenton, FL, USA.
Jia Bei WangDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
University of Maryland, Baltimore · USLake Erie College of Osteopathic Medicine · US

Funding

Development of I-THP as New Medication for Drug Addiction (DP1)DP1DA031401 · NIDA · UNIVERSITY OF MARYLAND BALTIMORE · PI WANG, JIA BEI · 2010 to 2015
$3.8M
NIDA NIH HHS DP1 DA031401
6 · The paper itself

Abstract

Cocaine use disorder (CUD) remains a significant public health challenge. l-Tetrahydropalmatine (l-THP), a well-tolerated and nonaddictive compound, shows promise for the management of CUD. Its pharmacologic profile includes blockade at dopamine and other monoamine receptors and attenuation of cocaine self-administration, reinstatement, and rewarding properties in rats. This study evaluated the safety of l-THP in human cocaine users and its influence on the safety and pharmacokinetics (PK) of cocaine. Twenty-four cocaine-using adult men were randomized to receive l-THP (30 mg twice a day orally) or placebo double-blind for 4 days, with an intranasal cocaine (40 mg) challenge on the fourth day. Safety and tolerability were evaluated using vital signs, ECG, clinical laboratory tests, and standardized self-report instruments. Peripheral venous blood was collected periodically and later assayed for l-THP and cocaine using highly sensitive and specific ultraperformance liquid chromatography-fluorescence detection (UPLC-FLD) methods. Twenty subjects completed the study, of whom 19 provided complete PK data. The short 3.5-day course of l-THP was safe and well tolerated and did not affect cocaine's PK or its acute cardiovascular effects. The cocaine AUC

Indexed as

Administration, IntranasalAdultBerberine AlkaloidsChromatography, High Pressure LiquidCocaineCocaine-Related DisordersDopamine AntagonistsDouble-Blind MethodElectrocardiographyHumansMaleMiddle AgedSpectrometry, FluorescenceBerberine AlkaloidsCocaineDopamine Antagoniststetrahydropalmatineaddiction medicinecentral nervous systemclinical pharmacologyclinical trialsdrug-drug interactionsdrug metabolismpharmacokinetics

Identifiers

PMID27363313
PMCPMC5203976
OpenAlexW2470106286

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.