Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: A randomized controlled trial

Abstract

Background Naltrexone provides excellent opioid blockade, but its clinical utility is limited because opioid-dependent patients typically refuse it. An injectable suspension of naltrexone for extended release (XR-NTX) was recently approved by the FDA for treatment of opioid dependence. XR-NTX treatment may require concurrent behavioral intervention to maximize adherence and effectiveness, thus we sought to evaluate employment-based reinforcement as a method of improving adherence to XR-NTX in opiate dependent adults. Methods Opioid-dependent adults (N = 38) were detoxified and inducted onto oral naltrexone, then randomly assigned to contingency or prescription conditions. Participants received up to six doses of XR-NTX at four-week intervals. All participants could earn vouchers for attendance and performance at a therapeutic workplace. Contingency participants were required to accept XRNTX injections to access the workplace and earn vouchers. Prescription participants could earn vouchers independent of their acceptance of XR-NTX injections. Results Contingency participants accepted significantly more naltrexone injections than prescription participants (87% versus 52%, p = .002), and were more likely to accept all injections (74% versus 26%, p = .004). Participants in the two conditions provided similar percentages of samples negative for opiates (72% versus 65%) and for cocaine (58% versus 54%).Opiate positivity was significantly more likely when samples were also cocaine positive, independent of naltrexone blockade (p = .002). Conclusions Long-term adherence to XR-NTX in unemployed opiate dependent adults is low under usual care conditions. Employment-based reinforcement can maintain adherence to XRNTX. Ongoing cocaine use appears to interfere with the clinical effectiveness of XR-NTX on opiate use.

Effects of Acute Oral Naltrexone on the Subjective and Physiological Effects of Oral D-Amphetamine and Smoked Cocaine in Cocaine Abusers

“…Some studies suggest that NTX may be useful for treating COC abuse (Kosten et al, 1989;McCaul and Svikis, 1996;Oslin et al, 1999;Schmitz et al, 2001;Comer et al, 2006) and others do not (Hersh et al, 1998;Schmitz et al, 2009;DeFulio et al, 2012;Dunn et al, 2012). In humans seeking treatment for COC dependence, NTX significantly increased the percentage of COC-negative urines among patients receiving 50 mg NTX plus relapse prevention therapy relative to those receiving 0 mg NTX plus relapse prevention, and those receiving 0 mg or 50 mg NTX plus drug counseling (Schmitz et al, 2001).…”

Antagonists in the medical management of opioid use disorders: Historical and existing treatment strategies

“…Combining XR‐NTX with employment‐based reinforcement has also been shown to be effective in unemployed adults 114. Others who may benefit include incarcerated persons and those without access to opioid agonist treatment 60, 71, 115.…”

Employment-based abstinence reinforcement following inpatient detoxification in HIV-positive opioid and/or cocaine-dependent patients.

“…For instance, all the preceding studies that have been conducted in the Therapeutic Workplace with opiate-dependent patients enrolled individuals who were receiving either methadone (Silverman et al, 2001; Silverman et al, 2002) or naltrexone (DeFulio et al, 2012; Dunn et al, 2013; Everly et al, 2011) to manage their opiate dependence. The successful results of these studies are consistent with a recent meta-analysis that reported opiate detoxification is most successful when a combination of pharmacological and psychosocial support is provided (Amato et al, 2011).…”

“…Three studies inducted recently detoxified opioid-dependent patients onto oral naltrexone and then randomly assigned participants either to a contingency group that was required to accept oral naltrexone (Dunn et al, 2013), or a 6-dose course of sustained release naltrexone administered every 3 (Everly et al, 2011) or 4 (DeFulio et al, 2012) weeks to enter the workplace, or to a usual care condition that had access to the naltrexone product but could enter the workplace independent of naltrexone adherence. Results of all three studies showed improved adherence to naltrexone dosing in contingency versus control participants.…”