Phase 2
N=103
Medications Development for Drug Abuse Disorders
Opioid Related Disorders · Opioid Dependence · Opioid Addiction
Bottom Line
View on ClinicalTrials.gov: NCT01188421 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. — 7.79; 8.41; 8.28; 6.16 units on a scale — p=.275
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buprenorphine/naloxone (Drug); Clonidine (Drug); Tramadol ER (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. |
7.79; 8.41; 8.28; 6.16; 6.10; 8.00 | .275 |
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.
Eligibility 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 Diagnostic and Statistical Manual of Mental Disorders (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.
Data sourced from ClinicalTrials.gov (NCT01188421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.