Drug AbusePhase 2NCT00671632
Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse
A Phase 2 study of Drug Abuse, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Drug Abuse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Must be in good health as determined by a physician (ie, via medical history and physical examination).
- Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
- Must have a history of substance abuse or dependence, on a commonly abuse recreational psychoactive drug (e.g., benzodiazepines, cocaine, opiates, cannabinoids).
- Must have a negative urine sample for substances of abuse and a negative breathalyzer test before the first dose of study medication is administered.
- Must be free of any signs/symptoms of withdrawal from substances after admittance to the research unit and prior to the first dose of study medication.
- Must report liking for study medication given on Day -2 and liking must be of greater magnitude that than the liking for study medication given on Day -1.
Who cannot join
- Known hypersensitivity to ramelteon or related compounds including melatonin.
- Known hypersensitivity to benzodiazepines or related compounds.
- Current diagnosis of any type of physical drug dependence other than nicotine or caffeine.
- Positive HBsAg are excluded.
- Positive human immunodeficiency virus antibody at screening.
- Diastolic blood pressure greater than 90 mm Hg or a systolic pressure of greater than 140 mm Hg at screening.
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- Previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
- Body weight is less than 99 or greater than 264 pounds. Subjects that are morbidly obese as defined by greater than 2 times ideal body weight
- Significant urine concentration of any drug that could interfere with the study.
- Clinically significant abnormal finding on physical examination or electrocardiogram. Subjects with a clinically significant illness in the past 30 days.
- Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised diagnosis of a serious psychiatric condition (e.g. Schizophrenia, Major Depression).
- Currently is participating in another investigational study or has participated in an investigational study within the past 30 days.
- Any other serious disease or condition at screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Center, Double-Blind, Multiple-Dose, Placebo-Controlled, Crossover, Double-Dummy Study of The Acute Behavioral and Subjective Effects of Ramelteon in Subjects With a History of Polydrug Abuse.
The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.
Read the detailed description
Insomnia is characterized by a complaint of either difficulties initiating and maintaining sleep, or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Participation in this study is anticipated to be about 1 month.
- Conditions
- Drug Abuse
- Being tested
- Ramelteon, triazolam, and placebo (56 possible combinations total)
- Keywords
- Addiction
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon, triazolam, and placebo (56 possible combinations total)Drug
Also called Rozerem™, TAK-375
Randomized sequence over eight consecutive days to include the following:
Ramelteon 16 mg, tablets, orally, one day only;
Ramelteon 80 mg, tablets, orally, one day only;
Ramelteon 160 mg, tablets, orally, one day only;
Triazolam 0.25 mg, capsules, orally, one day only;
Triazolam 0.50 mg, capsules, orally, one day only;
Triazolam 0.75 mg, capsules, orally, one day only;
Ramelteon placebo-matching tablets, orally, one day only, OR Triazolam placebo-matching capsules, orally, one day only;
Additional dose of study medication or placebo, tablets or capsules, orally, one day only.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon, triazolam, and placebo (56 poss. combinations) | Experimental | Ramelteon, triazolam, and placebo (56 possible combinations total) Receives: Drug: Ramelteon, triazolam, and placebo (56 possible combinations total) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Secondary outcomes (18)
Next Day Questionnaire.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Addiction Research Center Inventory.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Effect Questionnaire.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Subjective Effects Questionnaire.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Pharmacologic Class Questionnaire.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Versus Money Multiple Choice Procedure.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Observer Rated Questionnaire.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Word Recall/Recognition Task.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Enter and Recall Task.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Balance task.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Digit Symbol Substitution Task.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Circular lights task.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Neuropsychometric Testing
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Adverse Events
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Laboratory Test Results
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Vital Signs
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Electrocardiograms
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Physical Examination Findings.
Measured: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJun 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671632
- Sponsor's protocol ID
- 01-02-TL-375-015
- Other IDs
- U1111-1114-3109
- Status last verified
- Feb 2012
- First submitted
- 1 May 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. doi: 10.1001/archpsyc.63.10.1149.
PubMed 17015817
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Double-Blind, Multiple-Dose, Placebo-Controlled, Crossover, Double-Dummy Study of The Acute Behavioral and Subjective Effects of Ramelteon in Subjects With a History of Polydrug Abuse.
- ClinicalTrials.gov ID
- NCT00671632
- Acronym / sponsor ID
- 01-02-TL-375-015
- Conditions
- Drug Abuse
- Keywords
- Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.
Detailed description
Insomnia is characterized by a complaint of either difficulties initiating and maintaining sleep, or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Participation in this study is anticipated to be about 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon, triazolam, and placebo (56 poss. combinations) | Experimental | Drug: Ramelteon, triazolam, and placebo (56 possible combinations total)Ramelteon, triazolam, and placebo (56 possible combinations total) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Must be in good health as determined by a physician (ie, via medical history and physical examination).
- Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
- Must have a history of substance abuse or dependence, on a commonly abuse recreational psychoactive drug (e.g., benzodiazepines, cocaine, opiates, cannabinoids).
- Must have a negative urine sample for substances of abuse and a negative breathalyzer test before the first dose of study medication is administered.
Key exclusion criteria (14 listed)
- Known hypersensitivity to ramelteon or related compounds including melatonin.
- Known hypersensitivity to benzodiazepines or related compounds.
- Current diagnosis of any type of physical drug dependence other than nicotine or caffeine.
- Positive HBsAg are excluded.
- Positive human immunodeficiency virus antibody at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramelteon, triazolam, and placebo (56 possible combinations total)Also: Rozerem™, TAK-375Randomized sequence over eight consecutive days to include the following: Ramelteon 16 mg, tablets, orally, one day only; Ramelteon 80 mg, tablets, orally, one day only; Ramelteon 160 mg, tablets, orally, one day only; Triazolam 0.25 mg, capsules, orally, one day only; Triazolam 0.50 mg, capsules, orally, one day only; Triazolam 0.75 mg, capsules, orally, one day only; Ramelteon placebo-matching tablets, orally, one day only, OR Triazolam placebo-matching capsules, orally, one day only; Additional dose of study medication or placebo, tablets or capsules, orally, one day only. | Drug | Ramelteon, triazolam, and placebo (56 poss. combinations) |
Primary outcome
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
18 secondary outcomes
Next Day Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Addiction Research Center Inventory.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Effect Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Subjective Effects Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Pharmacologic Class Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Drug Versus Money Multiple Choice Procedure.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Observer Rated Questionnaire.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Word Recall/Recognition Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Enter and Recall Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Balance task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Digit Symbol Substitution Task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Circular lights task.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Neuropsychometric Testing
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Adverse Events
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Laboratory Test Results
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Vital Signs
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Electrocardiograms
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Physical Examination Findings.
Time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Results publication: PubMed 17015817Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. doi: 10.1001/archpsyc.63.10.1149.
- Rozerem Package InsertLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Drug Abuse, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak liking score from the Drug Effect Questionnaire as recorded during the 24 hours following administration. (time frame: Days 1, 2, 3, 4, 5, 6, 7, and 8 or Final Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.