A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Opioid Dependence Clinical Trial

Official title:

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01136356
• Other study ID #: NIDA-08045-9
• Secondary ID: R01DA008045DPMC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 2, 2010
• Last updated: April 16, 2015
• Start date: July 2010
• Est. completion date: June 2016

Study information

• Verified date: April 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Be adults ranging in age from 21-55 years old.

• Be dependent on opioids.

• Be willing to accept or desiring of opioid detoxification.

• He healthy as determined by medical screen, history, and vitals.

• Be without significant psychiatric illness besides drug dependence.

• Be without chronic pain.

• Fluent in English (speaking, writing, and reading).

• Be willing and able to participate.

Exclusion Criteria:

• Previous documented allergy to buprenorphine or morphine.

• Are dependent on other drugs besides opioids and tobacco.

• Have current history of significant use of alcohol or sedative/hypnotics.

• Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.

• Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).

• Have an abnormal or prolongation of the QTc interval on a baseline electrocardiogram (ECG).

• Are seeking treatment for their substance dependence.

Study Design

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

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid Dependence

Intervention

Drug:
• buprenorphine
parenteral buprenorphine may be administered at multiple times each day
• morphine
parenteral morphine may be administered multiple times each day

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid withdrawal assessments	standard subject and observer ratings of opioid withdrawal will be collected at multiple time points each day	multiple times throughout day	Yes
Secondary	opioid agonist effects	standard observer and subject ratings of opioid agonist effects will be collected at multiple time points each day	multiple times throughout day	Yes
Secondary	pain assessments	a battery of standard pain assessments will be conducted over the approximately 9 weeks of this study	10 times over course of the study	No
Secondary	sleep measures	standard sleep assessments will be collected each day of the study	daily	No