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A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

Primary Purpose

Cocaine Dependence, Opiate Dependence

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Atomoxetine, low dose

Atomoxetine, high dose

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring addiction, cocaine, methadone, opiates, atomoxetine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Men and women between 18 and 65 years old.
- Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
- Diagnosis of opioid dependence and cocaine dependence by Diagnostic and Statisical Manual (DSM-IV) -criteria as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
- For those who recently participated in a research study, at least 2 weeks of washout period before enrollment.
- A history of cocaine use,( a minimum of 1/2 gram during the preceding 30 days).
- Must be seeking treatment for opioid and cocaine use.
- For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

• Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;
- Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
- Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
- Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- Has not been treated with monoamine oxidase inhibitors within the last fourteen days.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Known allergy or intolerance to atomoxetine.

Sites / Locations

Department of Veterans Affairs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atomoxetine, low dose

Atomoxetine, high dose

Placebo (sugar pill)

Arm Description

1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.

One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules

1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.

Outcomes

Primary Outcome Measures

Treatment Retention

The number of participants completing all 8 weeks of treatment phase.

Secondary Outcome Measures

Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale

Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).

Full Information

NCT ID

NCT01802515

First Posted

February 27, 2013

Last Updated

October 13, 2016

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01802515

Brief Title

A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

Official Title

Atomoxetine Treatment for Opioid Maintained Cocaine Users

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Terminated

Why Stopped

No funding stopped recruitment march 2014 with only 14 enrolled

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above support the safety of atomoxetine in combination with stimulants. As the next step, the investigators will evaluate the safety and tolerability of atomoxetine in a small clinical trial with cocaine users. If atomoxetine is found to be promising in this study and sufficiently powered, double-blind, placebo-controlled studies will be proposed.

Detailed Description

This will be an approximately 13 to 14 week double-blind, placebo-controlled clinical trial testing the safety and feasibility of atomoxetine (40 or 80 mg/day) treatment, compared to placebo, in methadone-stabilized stimulant users. The study will have 3 phases: 1) a one to two week- methadone-induction phase; 2) an 8-week "treatment" phase; and 3) 1 week atomoxetine taper and about a 4-week methadone "taper and detoxification or transfer" phase. Subjects will be randomized to three treatment arms: 40 mg (n=15) atomoxetine, or 80 mg (n=15) atomoxetine, or placebo (n=15). During the methadone induction phase, subjects will be stabilized on methadone. During induction onto methadone, participants will be administered increasing doses of methadone starting at 30 mg daily, and this dose will be increased for stabilization of opiate withdrawal symptoms from 40 mg up to 140 mg depending on individual need. Based on the clinic schedule between 1 to 2 weeks after methadone treatment is initiated , atomoxetine treatment will be started at 40 mg/day. For those assigned to 80 mg of atomoxetine, the dose will be titrated up to 80 mg/day on the second week of treatment phase. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 4-week period based on an individual's needs, and they will concurrently be tapered off atomoxetine. All participants will receive a weekly one-hour of individual psychotherapy (Cognitive Behavioral Therapy) with experienced clinicians specifically trained to deliver the therapy, and who will receive ongoing supervision. This study has been terminated as of march 2014 due to the lack of funding, only 14 were enrolled with 11 subject completers. (June 2016)

6. Conditions and Keywords

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

Cocaine Dependence, Opiate Dependence

Keywords

addiction, cocaine, methadone, opiates, atomoxetine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atomoxetine, low dose

Arm Type

Active Comparator

Arm Description

1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.

Arm Title

Atomoxetine, high dose

Arm Type

Active Comparator

Arm Description

One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules

Arm Title

Placebo (sugar pill)

Arm Type

Placebo Comparator

Arm Description

1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.

Intervention Type

Drug

Intervention Name(s)

Atomoxetine, low dose

Other Intervention Name(s)

Strattera,, National Drug Codes - 00002-3229

Intervention Description

The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.

Intervention Type

Drug

Intervention Name(s)

Atomoxetine, high dose

Other Intervention Name(s)

Strattera, National Drug Codes - 00002-3250

Intervention Description

The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

sugar pill

Intervention Description

The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.

Primary Outcome Measure Information:

Title

Treatment Retention

Description

The number of participants completing all 8 weeks of treatment phase.

Time Frame

8 weeks of treatment

Secondary Outcome Measure Information:

Title

Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale

Description

Time Frame

8 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Men and women between 18 and 65 years old. Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates. Diagnosis of opioid dependence and cocaine dependence by Diagnostic and Statisical Manual (DSM-IV) -criteria as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry. For those who recently participated in a research study, at least 2 weeks of washout period before enrollment. A history of cocaine use,( a minimum of 1/2 gram during the preceding 30 days). Must be seeking treatment for opioid and cocaine use. For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests. Exclusion Criteria: • Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders; Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder. Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met. Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis. Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone. Has not been treated with monoamine oxidase inhibitors within the last fourteen days. Liver function tests (ALT or AST) greater than 3 times normal. Known allergy or intolerance to atomoxetine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Sofuoglu, M.D,Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Veterans Affairs Hospital

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

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