CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Talwin Nxdrug
Likely dose
Talwin NX 50 mg orally twice dailyAI-extracted
Key inclusion· 2
  • Young Mania Rating Scale (YMRS) score greater than 14
  • Must be an inpatient
Key exclusion· 5
  • History of opioid abuse or dependence
  • Recent history of substance abuse
  • Pregnancy
  • Unstable medical conditions

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00125931
NCT00125931Phase 2Completed

Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

Mclean Hospital·interventional·Posted Aug 2, 2005·Updated Sep 4, 2014

In Brief

A Phase 2 clinical trial evaluating Talwin Nx for Bipolar Disorder. Completed, enrolled 10 participants.

Detailed Summary

The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2005
Enrollment StartSep 1, 2005
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.9 years ago

Interventions

Talwin Nxdrug

Talwin NX 50mg po twice