Substance-Related Disorders Clinical Trial
Official title:
PK 0396 - Buprenorphine Dose Escalation Trial
The purpose of this study is to evaluate the effect, pharmacokinetics and dose proportionality of buprenorphine when administered to non-dependent opiate users. 1) To evaluate whether plasma concentrations of buprenorphine increase proportionally to buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects of buprenorphine; and 3) To determine the safety of buprenorphine.
This will be an open-label, single dose-escalation trial. A total of 24 opiate experienced,
but not dependent subjects will receive four ascending doses of buprenorphine, 4, 8, 16, and
24 mg, respectively, with an at least a 14 day washout interval between treatments. The four
treatments are sublingual administration of:
1. two 2-mg buprenorphine sublingual tablets,
2. one 8-mg buprenorphine sublingual tablet,
3. two 8-mg buprenorphine sublingual tablets; and
4. three 8-mg buprenorphine sublingual tablets.
The dose proportionality in plasma profiles of buprenorphine and dose response of the
buprenorphine sublingual tablets are evaluated at buprenorphine dose range of 4 to 24 mg.
;
Primary Purpose: Treatment
| 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 |
NCT02570360 -
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
|
N/A | |
| Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
| Completed |
NCT02125539 -
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
|
Phase 2 | |
| Completed |
NCT02388243 -
The Computer-based Drug and Alcohol Training Assessment in Kenya
|
N/A | |
| 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 |