Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia

NCT00218374 | Completed

• 3 other identifiers: NIDA-15463-1R01-15463-1DPMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals who reduce or stop use of opioid medications are at risk for developing hyperalgesia, which is an increased sensitivity to pain. This study will compare the effectiveness of dextromethorphan, gabapentin, and oxycodone at reducing hyperalgesia in individuals addicted to opioids who are concurrently receiving methadone treatment.

Conditions

Hyperalgesia; Opioid-Related Disorders

Keywords

Opiate Addiction; Opiate Dependence

Outcome Measures

Primary Outcomes (1)

• Pain response (measured after each pain testing session on Days 1, 4, 36, and 39)

  6 week

Interventions

Gabapentin DRUG

Gabapentin initiated up to a daily dose of 2400mg PO x 5 weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 55 years of age.
• Meets DSM-IV diagnostic criteria for opioid dependence
• Taking a stable dose of methadone for 6 weeks prior to study entry and is compliant in methadone maintenance treatment
• Is in good physical health or under a physician's care if a medical condition requires ongoing treatment

You may not qualify if:

• Known sensitivity to dextromethorphan, gabapentin, or oxycodone
• Currently dependent on alcohol, benzodiazepine, or any drug (other than nicotine)
• Currently in an acutely psychotic, severely depressed state and in need of inpatient treatment
• Immediate suicide risk
• Neurological or psychiatric illness (e.g., peripheral neuropathy, schizophrenia, neuropathic pain, Raynaud's disease, or urticaria)
• Acute medical condition that would make study participation medically dangerous (e.g., acute hepatitis, unstable cardiovascular disease, liver disease, or kidney disease)
• Liver enzyme values five times greater than normal
• Currently taking analgesic medication for a painful condition on a regular basis
• Current or past history of high blood pressure, heart disease, or stroke
• Currently using a pacemaker
• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Hyperalgesia; Opioid-Related Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Margaret Compton, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2008-08

Locations

US (1)