Assessment of Tramadol as a Treatment for Opioid Addiction

Status Completed

Clinical Trial 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.

Clinical Trial Description

This human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence. Tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence. Tramadol's capacity for producing physical dependence has not been systematically studied in humans. It is important to quantify tramadol, as it provides a measure of its opioid agonist effects. This would also be informative in regards to the abuse liability of tramadol when used as an analgesic (as currently marketed), or when used in the treatment of opioid addiction (as proposed in this study). The purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals.

Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. Experimental sessions will take place up to three times per week during the treatment period. During challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. First, no effect may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Opioid-Related Disorders

Clinical Trial Details

NCT number	NCT00301210
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2006
Completion date	November 2007

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03950492` - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder	N/A
Completed	`NCT00000335` - Activity Monitoring Assessment of Opiate Withdrawal - 4	Phase 2
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Enrolling by invitation	`NCT06084221` - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems	N/A
Completed	`NCT02978417` - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings	Phase 4
Withdrawn	`NCT03137030` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults	Phase 1
Withdrawn	`NCT03137017` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults	Phase 1
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Completed	`NCT00710385` - Abuse Liability of Suboxone Versus Subutex	Phase 3
Completed	`NCT00142935` - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1	N/A
Completed	`NCT00218309` - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals	Phase 2
Terminated	`NCT00000243` - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone	N/A
Completed	`NCT00067184` - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Completed	`NCT00000264` - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16	N/A
Completed	`NCT00000257` - Effects of Alcohol History on Effects of Nitrous Oxide - 9	N/A
Completed	`NCT00000279` - Novel Medications for Opiate Detoxification - 4	Phase 2
Completed	`NCT00000306` - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3	Phase 2
Completed	`NCT00000249` - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1	Phase 2
Recruiting	`NCT04933084` - Pre-operative Education Modalities to Decrease Opioid Use	N/A
Recruiting	`NCT03610672` - Mobile Intervention for Young Opioid Users	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.