Medications Development for Drug Abuse Disorders

NCT01188421 | Completed Phase 1 Results

• 4 other identifiers: NIDA-018125NA_00037871R01DA018125DPMC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Related Disorders; Opioid Dependence; Opioid Addiction

Outcome Measures

Primary Outcomes (1)

• Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.

  Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.

  14 days total

Study Arms (3)

buprenorphine

ACTIVE COMPARATOR

Sublingual buprenorphine/naloxone tablets (or placebo)

Drug: Buprenorphine/naloxone

clonidine

ACTIVE COMPARATOR

Oral clonidine tablets (or placebo)

Drug: Clonidine

tramadol ER

EXPERIMENTAL

Oral tramadol tablets (or placebo)

Drug: Tramadol ER

Interventions

Buprenorphine/naloxone DRUG

up to 8/2 mg Sublingual (SL) per day

Also known as: Suboxone

buprenorphine

Clonidine DRUG

up to 0.8 mg per day (oral)

Also known as: Catapres

clonidine

Tramadol ER DRUG

up to 600 mg per day

Also known as: Ultram

tramadol ER

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Dunn KE, Tompkins DA, Bigelow GE, Strain EC. Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):885-893. doi: 10.1001/jamapsychiatry.2017.1838.

  PMID: 28700791 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Clonidine; Tramadol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Eric C. Strain, MD
• Organization: Johns Hopkins University, School of Medicine

estrain1@jhmi.edu

410-550-1191

Study Officials

• Eric C. Strain, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 25, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 6, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-06

Locations

US (1)