Recreational drug users being recruited for clinical trials

Wanted: drug abuser who enjoys snorting opioids. Will pay $250 a day.

Thousands of recreational drug users are being recruited to clinical trials for pharmaceutical companies including Pfizer and Teva, as the industry races to develop a new generation of “abuse-deterrent” opioid painkillers designed to stem America’s addiction to prescription drugs.

The US Food and Drug Administration has declared the problem a “national epidemic”. Official estimates put the number of opioid abusers in the US at 2.1m and overdoses are responsible for roughly 45 deaths a day.

One of the only ways of proving the new wave of “abuse-deterrent” pills are harder to abuse than existing opioid painkillers is to test whether real-life drug users enjoy taking them as much as the current crop of medicines.

Ronny Gal, an analyst at Bernstein Research, said such studies were “the dark underbelly of the drug-testing world”.

The drug users are recruited by research clinics on behalf of the pharma companies, housed in special accommodation, and paid between $250 and $300 a day for the trials, which can last up to a month.

One research clinic, Vince & Associates, was recently recruiting recreational drug users and offering to pay $3,700 for a 15-day study, although its focus was cocaine abuse rather than opioids.

During the ”double blind” trials, participants are given a mixture of pills — without being told whether they are existing opioids, new tamper-proof drugs, or placebos — and asked to abuse them, often by snorting them, or taking several at once. They must then rate how enjoyable the experience is.

The aim of the trials is to show that the newer abuse-deterrent drugs score less on a “drug-liking” scale.

The number of these drug-liking or “human abuse liability” studies has surged in the past two years as US authorities demand that pharma groups build abuse-deterrent technology into opioid painkillers.

Drugmakers are testing a range of approaches, from hard shells and coatings designed to make pills less enjoyable when chewed, snorted or injected, to so-called antagonists that counteract the effect of the opioid if the capsule is tampered with.

The FDA, the US drugs watchdog, has strongly encouraged pharma companies to conduct the drug-liking studies before requesting approval for new opioid-based painkillers.

“Studies should be conducted in opioid-experienced, recreational drug users who have experience with the particular route of abuse being studied,” the regulator said in final guidelines published in April.

There are only a handful of centres in North America equipped to conduct the trials, and they are in many cases running at full capacity. Lifetree Clinical Research in Salt Lake City, Utah, has seen the number of participants enrolled in its drug-liking studies jump from 267 in 2012 to 677 last year, according to figures seen by the Financial Times.

Lifetree has been contracted to run studies involving 582 participants so far this year. Shares in its parent company, PRA Health Sciences, have jumped nearly 90 per cent since its initial public offering on Nasdaq in November.

Pfizer paid at least $3.1m to Lifetree in 2014 to carry out human abuse liability studies last year, according to an FT analysis of public disclosures. It is developing a range of tamper-proof opioids including a version of oxycodone, a commonly abused painkiller.

A person who has participated in roughly 15 studies at Lifetree told the FT he was once asked to swallow 21 pills in five minutes to see if they would give him a sense of euphoria. Lifetree said the vast majority were placebos.

Toronto-based INC Research, PRA’s main competitor, also said it had experienced an increase in the number of drug companies testing their tamper-proof medicines. “There’s been a lot of volume around abuse-deterrence,” said Beatrice Setnik, a vice-president at INC.

This article is published in collaboration with The Financial Times. Publication does not imply endorsement of views by the World Economic Forum.

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Author: The Financial Times covers, comments and analyses the latest UK and international business, finance, economic and political news.

Image: Pharmaceutical tablets and capsules in foil strips are arranged on a table. REUTERS/Srdjan Zivulovic.

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