Medications Development for Drug Abuse Disorders
This study is currently recruiting participants.
Verified May 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01188421
First received: August 11, 2010
Last updated: May 4, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Related Disorders Opioid Dependence Opioid Addiction |
Drug: Buprenorphine/naloxone Drug: Clonidine Drug: Tramadol ER |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Medications Development for Drug Abuse Disorders |
Resource links provided by NLM:
Drug Information available for:
Naloxone hydrochloride
Clonidine
Clonidine hydrochloride
Tramadol
Buprenorphine
Buprenorphine hydrochloride
U.S. FDA Resources
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- change between groups over time in scores on a standard measure of opioid withdrawal signs and symptoms [ Time Frame: daily for approximately 4 weeks ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: buprenorphine |
Drug: Buprenorphine/naloxone
up to 8/2 mg SL per day
|
| Active Comparator: clonidine |
Drug: Clonidine
up to 0.8 mg per day (oral)
|
| Experimental: tramadol |
Drug: Tramadol ER
up to 600 mg per day
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188421
Contacts
| Contact: Hye Han | 410-550-0490 | hhan9@jhu.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University (BPRU) Bayview Campus | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Hye Han 410-550-0490 hhan9@jhu.edu | |
| Contact: Hye Han hhan9@jhu.edu | |
| Principal Investigator: Eric C. Strain, M.D. | |
| Sub-Investigator: David A. Tompkins, M.D. | |
| Sub-Investigator: George E. Bigelow, Ph.D. | |
| Sub-Investigator: Miriam Z. Mintzer, Ph.D. | |
| Sub-Investigator: Kelly Dunn, Ph.D. | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Eric C. Strain, M.D. | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Eric C. Strain, Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01188421 History of Changes |
| Other Study ID Numbers: | NIDA-018125, NA_00037871, R01DA018125, DPMC |
| Study First Received: | August 11, 2010 |
| Last Updated: | May 4, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Substance-Related Disorders Opioid-Related Disorders Behavior, Addictive Mental Disorders Compulsive Behavior Impulsive Behavior Buprenorphine Tramadol Naloxone Clonidine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013