A Systematic, Intensive Statistical Investigation of Data from the Comprehensive Analysis of Reported Drugs (CARD) for Compliance and Illicit Opioid Abstinence in Substance Addiction Treatment with Buprenorphine/naloxone

Abstract

Background: Buprenorphine and naloxone (bup/nal), a combination partial mu receptor agonist and low-dose delta mu antagonist, is presently recommended and used to treat opioid-use disorder. However, a literature review revealed a paucity of research involving data from urine drug tests that looked at compliance and abstinence in one sample. Method: Statistical analysis of data from the Comprehensive Analysis of Reported Drugs (CARD) was used to assess compliance and abstinence during treatment in a large cohort of bup/nal patients attending chemical-dependency programs from eastern USA in 2010 and 2011. Results: Part 1: Bup/nal was present in 93.4% of first (n = 1,282; p < .0001) and 92.4% of last (n = 1,268; p < .0001) urine samples. Concomitantly, unreported illicit drugs were present in 47.7% (n = 655, p = .0261) of samples. Patients who were compliant to the bup/nal prescription were more likely than noncompliant patients to be abstinent during treatment (p = .0012; odds ratio = 1.69 with 95% confidence interval (1.210, 2.354). Part 2: An analysis of all samples collected in 2011 revealed a significant improvement in both compliance (p < 2.2 × 10 −16 ) and abstinence (p < 2.2 × 10 −16 ) during treatment. Conclusion/Importance: While significant use of illicit opioids during treatment with bup/nal is present, improvements in abstinence and high compliance during maintenance-assisted therapy programs may ameliorate fears of diversion in comprehensive programs. Expanded clinical datasets, the treatment modality, location, and year of sampling are important covariates, for further studies. The potential for long-term antireward effects from bup/nal use requires consideration in future investigations.

Neurological correlates of brain reward circuitry linked to opioid use disorder (OUD): Do homo sapiens acquire or have a reward deficiency syndrome?

“…The current emphasis on opioid replacement in opioid use disorders (OUD) is a treatment based on a disease model that has not been proven. Oddly, the most efficacious treatments for OUDs are the treatments that stimulate compliance [ 172 ], are so closely related to opioid drugs of abuse, that the patient becomes addicted to the treatment, so discontinuation becomes unlikely [ 173 ]. The brain has not carved out an opiate (like codeine) or opioids (like buprenorphine) deficiency as a phenotypic target per se.…”

Therapeutic Drug Monitoring in Buprenorphine/Naloxone Treatment for Opioid Use Disorder: Clinical Feasibility and Optimizing Assay Precision

“…Therapeutic drug monitoring (TDM) is a procedure to determine the concentration of a target medication in blood to inform dose adjustment to increase the likelihood of the desired clinical response [9]. TDM has been recommended for monitoring adherence to BUP treatment [9], but to date it has not been implemented in routine clinical practice [10] due to a lack of data on clinical feasibility, cost-effectiveness [11], and, perhaps, the complexity of the procedure and the laboratory expertise required for accurate detection and quantitation of a target medication [5].…”

“…Medication-assisted treatment (MAT) with full and partial mu opioid receptor agonists (including buprenorphine [BUP] and buprenorphine/naloxone [BUP/NX]) is the first line, evidence-based pharmacotherapeutic intervention for people with OUD [4]. BUP/NX is associated with abstinence from opioids [5] and a 10-fold reduced risk of relapse [6]. However, patient non-compliance, medication diversion [7], and inappropriate treatment discontinuation [8] all limit the effectiveness of MAT.…”

Medication-Assisted Treatment for Opioid-Use Disorder

“…67,68 Benefits The clinical efficacy of buprenorphine for the treatment of OUD has been well established. [69][70][71][72] Buprenorphine compliance is quite high and is associated with improved rates of sobriety, decreased criminal activity outcomes, and reduction in accidental overdoses. 34,72 Challenges Despite its relative safety and efficacy in the treatment of OUDs, its widespread use continues to be relatively modest.…”