A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users

NCT01987739

Abuse Potential Study

COMPLETED PHASE1

Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users

NCT00902772

Recreational CNS Depressant Use

COMPLETED PHASE1

A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users

NCT03509285

Healthy Volunteer

COMPLETED PHASE1

A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users

NCT03286218

Recreational Drug Use Prescription Drug Abuse (Not Dependent)

COMPLETED PHASE1

(+)-Alpha-Dihydrotetrabenazine Phase I

NCT02844179

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main purpose for this study is to determine whether dimebon exhibits abuse potential.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Huntington's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dimebon 20 mg

Group Type EXPERIMENTAL

dimebon

Intervention Type DRUG

Oral tablet; 20 mg dimebon, single dose

dimebon 40 mg

Group Type EXPERIMENTAL

dimebon

Intervention Type DRUG

Oral tablet; 40 mg dimebon, single dose

dimebon 60 mg

Group Type EXPERIMENTAL

dimebon

Intervention Type DRUG

Oral tablet; 60 mg dimebon, single dose

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral tablet or capsule; placebo, single dose

alprazolam 1 mg

Group Type ACTIVE_COMPARATOR

alprazolam

Intervention Type DRUG

Oral capsule; 1 mg alprazolam, single dose

alprazolam 3 mg

Group Type ACTIVE_COMPARATOR

alprazolam

Intervention Type DRUG

Oral capsule; 3 mg alprazolam, single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dimebon

Oral tablet; 20 mg dimebon, single dose

Intervention Type DRUG

dimebon

Oral tablet; 40 mg dimebon, single dose

Intervention Type DRUG

dimebon

Oral tablet; 60 mg dimebon, single dose

Intervention Type DRUG

placebo

Oral tablet or capsule; placebo, single dose

Intervention Type DRUG

alprazolam

Oral capsule; 1 mg alprazolam, single dose

Intervention Type DRUG

alprazolam

Oral capsule; 3 mg alprazolam, single dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria

* History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
* A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
* Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
* History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No