Medications Development for Drug Abuse Disorders

Opioid Dependence Clinical Trial

Official title:

Medications Development for Drug Abuse Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188421
• Other study ID #: NIDA-018125
• Secondary ID: NA_00037871R01DA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 11, 2010
• Last updated: December 20, 2016
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: December 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion/Exclusion Criteria:

• Participants in this study will be males and females between the ages of 18 and 60 years.

• Applicants must be opioid dependent based upon the Structured Clinical Interview for DSM-IV (SCID); in addition, they must have an opioid positive urine during the screening process (or have evidence of opioid withdrawal).

• They must be healthy, with no significant medical illnesses (e.g., insulin dependent diabetes), and without significant psychiatric illness (e.g., schizophrenia) besides their drug dependence.

• Females will have a pregnancy test prior to study enrollment, and if found to be pregnant will be excluded and referred to a substance abuse program for pregnant women (the Center for Addiction and Pregnancy) on the campus.

• Volunteers will also be excluded if they have pre-admission hypotension (due to the use of clonidine in the study).

• Applicants with a history of seizures (including substance-related seizures, such as alcohol withdrawal related) will be excluded.

• Alcohol and/or sedative dependence will be specific exclusionary criteria (given the small risk of seizures associated with tramadol use).

• Allergies to any of the study medications will be grounds for exclusion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Opioid Addiction
• Opioid Dependence
• Opioid Related Disorders
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone
up to 8/2 mg SL per day
• Clonidine
up to 0.8 mg per day (oral)
• Tramadol ER
up to 600 mg per day

Locations

Country	Name	City	State
United States	Johns Hopkins University (BPRU) Bayview Campus	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	change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms	Participants in this study will be assessed for opioid withdrawal on a daily basis. The primary outcome measure for this assessment is the Clinical Opioid Withdrawal Scale (COWS), which is a well-established clinical assessment tool for quantifying the different signs and symptoms of opioid withdrawal. The COWS has been validated, and scores can range from 0 to 47. It is administered by a clinician on the ward.	daily for approximately 4 weeks	Yes