Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Michelle Lofwall

Status and phase: Completed; Phase 3; Phase 2

Conditions: Substance Withdrawal Syndrome

Treatments: Drug: Placebo; Drug: Tramadol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00980044

09-0489

R01DA027068 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Enrollment: 53 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Addicted to opioids

Exclusion criteria

• Any major medical or psychiatric disorder that would be contraindicated for participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 3 patient groups, including a placebo group

Tramadol 200 mg then placebo

Experimental group

Description:

Tramadol 200 mg daily for 1 week then placebo given for 1 week

Treatment:

Drug: Tramadol

Placebo for two weeks

Placebo Comparator group

Description:

Medication

Treatment:

Drug: Placebo

Tramadol 600 mg then placebo

Experimental group

Description:

Tramadol 600 mg daily given for 1 week given then placebo given for 1 week

Treatment:

Drug: Tramadol