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

NCT01802515 | Terminated Results DMC

• 1 other identifier: 1206010407
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence; Opiate Dependence

Keywords

addiction; cocaine; methadone; opiates; atomoxetine

Outcome Measures

Primary Outcomes (1)

• Treatment Retention

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

  8 weeks of treatment

Secondary Outcomes (1)

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

  8 weeks of treatment

Study Arms (3)

Atomoxetine, low dose

ACTIVE COMPARATOR

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

Drug: Atomoxetine, low dose

Atomoxetine, high dose

ACTIVE COMPARATOR

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

Drug: Atomoxetine, high dose

Placebo (sugar pill)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Atomoxetine, low dose DRUG

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

Also known as: Strattera,, National Drug Codes - 00002-3229

Atomoxetine, low dose

Atomoxetine, high dose DRUG

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

Also known as: Strattera, National Drug Codes - 00002-3250

Atomoxetine, high dose

Placebo DRUG

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

Also known as: sugar pill

Placebo (sugar pill)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Department of Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders; Behavior, Addictive

Interventions

Atomoxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Carbohydrates

Limitations and Caveats

Study terminated after 14 subjects enrolled. 11 completers. 3 subjects dropped out in treatment week 7. There were no serious adverse events. Only descriptive statistics were computed.

Results Point of Contact

• Title: Dr. Mehmet Sofuoglu, Principal Investigator
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203 937-4809

Study Officials

• Mehmet Sofuoglu, M.D,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 6, 2016
• Results First Posted: December 6, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)