Evidence map›Paper›PMID 33281447›Full record

ArticleSubstance abuse : research and treatment2020

Feasibility and Preliminary Efficacy of Isradipine During Outpatient Buprenorphine Stabilization and Detoxification: A Pilot Randomized, Placebo-Controlled Trial.

Nihit Kumar, Michael J Mancino, Jeff D Thostenson, Janette McGaugh, Alison H Oliveto

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Substance abuse : research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01895270 (Improving Buprenorphine Detoxification Outcomes With Isradipine), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 32% 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.

NCT01895270 phase1 / phase2completednot on this map

Improving Buprenorphine Detoxification Outcomes With Isradipine

TypeinterventionalSponsorUniversity of ArkansasRan2013 to 2016Enrolled28ConditionsOpioid DependenceArmsIsradipine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
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

5 authors at 1 institution in 1 country.

Nihit KumarDepartment of Psychiatry and Behavioral Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.ORCID https://orcid.org/0000-0002-3728-6335
Michael J MancinoDepartment of Psychiatry and Behavioral Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Jeff D ThostensonDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Janette McGaughOuachita Behavioral Health and Wellness, Hot Springs, AR, USA.
Alison H OlivetoDepartment of Psychiatry and Behavioral Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
University of Arkansas for Medical Sciences · US

Funding

Improving Treatment Outcomes for Prescription Opioid DependenceR01DA039088 · NIDA · UNIV OF ARKANSAS FOR MED SCIS · PI MANCINO, MICHAEL J, OLIVETO, ALISON · 2015 to 2019
$2.9M
Improving Buprenorphine Detoxification Outcomes with IsradipineR21DA035325 · NIDA · UNIV OF ARKANSAS FOR MED SCIS · PI OLIVETO, ALISON · 2013 to 2014
$406k
NIDA NIH HHS R01 DA039088NIDA NIH HHS R21 DA035325
6 · The paper itself

Abstract

backgroundGiven the immense burden of the widespread use of opioids around the world, exploring treatments that improve drug use outcomes, and craving and withdrawal measures in individuals with opioid use disorder is crucial. This pilot study examined the feasibility and preliminary efficacy of the L-type calcium-channel blocker isradipine (ISR) to improve drug use outcomes, and craving and withdrawal measures during buprenorphine (BUP)/ISR stabilization and subsequent taper in opioid-dependent individuals.

methodsParticipants were stabilized on BUP sublingual tablets within the first 2 days of week 1, were then randomized and inducted on either ISR or placebo, gradually increasing the dose over the next 2 weeks, followed by a 10-day BUP taper during weeks 5-6, and ISR/placebo taper during weeks 7 to 8. Assessments included thrice-weekly measures of craving and withdrawal, as well as vital signs and urine drug screens. Medication compliance was assessed by monitoring number of missed clinic visit days.

resultsBaseline characteristics of participants (n = 25; 60% male, 96% Caucasian, 48% employed, mean age 32.8 years) did not differ significantly between treatment groups (isradipine, n = 11; placebo, n = 14). During the stabilization phase (n = 19), ISR participants had significantly lower rates of illicit opioid-positive urines (treatment × visit:

conclusionsThis study was likely underpowered due to being a pilot trial. Although preliminary results suggest ISR may improve BUP-assisted treatment outcomes, concerns about high number of exclusions (n = 11 during taper phase) based on cardiovascular measures as well as ISR-induced changes in vital signs with the immediate release formulation may limit the feasibility of this approach.

trial registrationClinicaltrials.gov identifier NCT01895270. Registered 10 July 2013, https://clinicaltrials.gov/ct2/show/NCT01895270?id=NCT01895270&draw=2&rank=1.

Indexed as

Buprenorphinecalcium-channel blockerdetoxificationisradipineopioid withdrawal

Identifiers

PMID33281447
PMCPMC7686602
OpenAlexW3109104549

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.