Medications Development for Drug Abuse Disorders
| Status: | Completed |
|---|---|
| Conditions: | Constipation, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/22/2016 |
| Start Date: | October 2010 |
| End Date: | June 2015 |
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
