NCT00301210

Brief Summary

Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

March 9, 2006

Last Update Submit

April 16, 2015

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (4)

  • Self-reported effects

    up to 4 hours for acute effects

  • physiologic measures

    up to 4 hours for acute effects

  • observer ratings of effects

    up to 4 hours for acute effects

  • cognitive/performance measures

    up to 4 hours for acute effects

Study Arms (2)

1

EXPERIMENTAL

tramadol dose 1

Drug: Tramadol

2

EXPERIMENTAL

tramadol dose 2

Drug: Tramadol

Interventions

TramadolDRUG

oral doses four times per day

Also known as: Ultram
12

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Currently opioid dependent

You may not qualify if:

  • Significant medical illness (e.g., diabetes mellitus)
  • History of seizure
  • Current sedative or alcohol dependence
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Lanier RK, Lofwall MR, Mintzer MZ, Bigelow GE, Strain EC. Physical dependence potential of daily tramadol dosing in humans. Psychopharmacology (Berl). 2010 Sep;211(4):457-66. doi: 10.1007/s00213-010-1919-3. Epub 2010 Jun 30.

    PMID: 20589494RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 10, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)