Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Condition: Opioid Dependence; Opioid Withdrawal; Opioid Detoxification
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine
Intervention description: Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opioid dependent; detoxification; buprenorphine; suboxone; opiate

Summary:

      This study involves inducting treatment seeking opioid dependent participants onto
      buprenorphine. Once the participant reaches a stable dose they will receive either placebo or
      gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant
      undergoes a 10-day buprenorphine detoxification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability to attend clinic 6 days a week for approximately 30-60 minutes.

          -  Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will
             be ascertained in the following manner: the physician will determine whether the
             individual is appropriate based on several clinical assessments that are routinely
             employed by methadone program physicians, including history and severity of opioid
             use, presence of track marks, prior treatment history, self-reported and/or observed
             signs and symptoms of opioid withdrawal. If any individual's degree of opioid
             dependence is questionable, that person will be excluded from further consideration as
             a participant.

          -  Participants must submit a urine negative for drugs of abuse other than opioids prior
             to starting the study.

        Exclusion Criteria:

          -  Unstable medical condition or stable medical condition that would interact with study
             medications or participation.

          -  History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)

          -  Pregnancy or plans to become pregnant or inadequate birth control (adequate birth
             control includes abstinence, condoms, birth control pills, etc).

          -  Present or recent use of over-the-counter psychoactive drug, prescription psychoactive
             drug or drug (including Maalox) that would have major interaction with drugs to be
             tested.

          -  Liver function tests greater than 3 times normal, BUN and Creatinine outside normal
             range, or thyroid function tests outside normal range.

          -  EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc
             interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd
             degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle
             branch block.

          -  Physical dependence on alcohol or drugs other than opioids or tobacco (as determined
             by physician assessment).