Back to results

Medications Development for Drug Abuse Disorders

Primary Purpose

Opioid Related Disorders, Opioid Dependence, Opioid Addiction

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine/naloxone

Clonidine

Tramadol ER

About this trial

This is an interventional treatment trial for Opioid Related Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins University (BPRU) Bayview Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

buprenorphine

clonidine

tramadol ER

Arm Description

Sublingual buprenorphine/naloxone tablets (or placebo)

Oral clonidine tablets (or placebo)

Oral tramadol tablets (or placebo)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01188421

First Posted

August 11, 2010

Last Updated

June 6, 2017

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01188421

Brief Title

Medications Development for Drug Abuse Disorders

Official Title

Medications Development for Drug Abuse Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Related Disorders, Opioid Dependence, Opioid Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

buprenorphine

Arm Type

Active Comparator

Arm Description

Sublingual buprenorphine/naloxone tablets (or placebo)

Arm Title

clonidine

Arm Type

Active Comparator

Arm Description

Oral clonidine tablets (or placebo)

Arm Title

tramadol ER

Arm Type

Experimental

Arm Description

Oral tramadol tablets (or placebo)

Intervention Type

Drug

Intervention Name(s)

Buprenorphine/naloxone

Other Intervention Name(s)

Suboxone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clonidine

Other Intervention Name(s)

Catapres

Intervention Description

up to 0.8 mg per day (oral)

Intervention Type

Drug

Intervention Name(s)

Tramadol ER

Other Intervention Name(s)

Ultram

Intervention Description

up to 600 mg per day

Primary Outcome Measure Information:

Title

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

Description

Time Frame

14 days total

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric C. Strain, M.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University (BPRU) Bayview Campus

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28700791

Citation

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. Erratum In: JAMA Psychiatry. 2017 Sep 1;74(9):975. JAMA Psychiatry. 2018 Apr 1;75(4):409.

Results Reference

derived

Learn more about this trial

Medications Development for Drug Abuse Disorders

We'll reach out to this number within 24 hrs