A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

NCT ID: NCT01136356

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-03-31

Brief 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.

Conditions

Opioid Abuse; Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Morphine, then Buprenorphine

Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.

Group Type: EXPERIMENTAL

buprenorphine

Intervention Type: DRUG

parenteral buprenorphine may be administered at multiple times each day

morphine

Intervention Type: DRUG

parenteral morphine may be administered multiple times each day

Buprenorphine, then Morphine

Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.

Group Type: EXPERIMENTAL

buprenorphine

Intervention Type: DRUG

parenteral buprenorphine may be administered at multiple times each day

morphine

Intervention Type: DRUG

parenteral morphine may be administered multiple times each day

Interventions

buprenorphine

parenteral buprenorphine may be administered at multiple times each day

Intervention Type: DRUG

morphine

parenteral morphine may be administered multiple times each day

Intervention Type: DRUG

Eligibility Criteria

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 corrected QT interval (QTc) on a baseline electrocardiogram (ECG).
• Are seeking treatment for their substance dependence.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Strain, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

References

Tompkins DA, Smith MT, Mintzer MZ, Campbell CM, Strain EC. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014 Feb;348(2):217-26. doi: 10.1124/jpet.113.209478. Epub 2013 Nov 13.

Reference Type: RESULT

PMID: 24227768 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/24227768

A double Blind, within Subjects Comparison of Spontaneous Opioid Withdrawal from Buprenorphine versus Morphine

Other Identifiers

R01DA008045

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

NIDA-08045-9

Identifier Type: -

Identifier Source: org_study_id