Prescription Opioid Addiction Treatment Study (POATS)

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.

Clinical Trial Description

This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00316277
Study type	Interventional
Source	Mclean Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	May 2006
Completion date	January 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Enrolling by invitation	`NCT06084221` - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems	N/A
Completed	`NCT02907944` - Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation	N/A
Completed	`NCT02829970` - Helping College Students With ADHD Lead Healthier Lifestyles	N/A
Completed	`NCT02570360` - Exercise and Treatment-as-usual in Substance Use Treatment Outcomes	N/A
Completed	`NCT02388243` - The Computer-based Drug and Alcohol Training Assessment in Kenya	N/A
Completed	`NCT02125539` - Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment	Phase 2
Completed	`NCT02715557` - Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT02218970` - The Effect of Muscular Strength Training in Patients With Drug Addiction	N/A
Completed	`NCT01633138` - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy	N/A
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Withdrawn	`NCT01224002` - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine	N/A
Withdrawn	`NCT00891631` - Primary Care iSBIRT to Reduce Serious Teen Health Risks	Phase 1/Phase 2
Completed	`NCT00970372` - Dual-Diagnosis and Compulsory Treatment	N/A
Completed	`NCT01365247` - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT00419029` - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment	N/A