Post by adriancolumb on Mar 18, 2015 16:41:31 GMT
Are you or do you know an adult (18+) in the UK who is willing to be a test subject in a study of a new medicine for ADHD?
There is currently a pilot study of treating ADHD using Sativex cannabinoid spray under way at the King's College in London that you can read about at www.clinicaltrials.gov/ct2/show/study/NCT02249299.
They still need to recruit a few adult test subjects!
The best candidates for the study:
1. Have a diagnosis of ADHD
2. Do not use cannabis on a regular basis or are willing to stop for 1 month prior to entering the study
3. Would not be on stimulant medicines or willing to stop for duration of the trial
4. Can visit the centre at King's College in London on 2 occasions at the start of the trial and 6-weeks later
Anyone interested should email Professor Asherson (philip.asherson@kcl.ac.uk).
When this important work is completed we will have broadened our understanding of treating ADHD. The study's significance is monumental as it will lay important groundwork for further research into treating ADHD such as a full-scale clinical trial which allows this promising new medicine to be prescribed for ADHD around the world.
If you fit the criteria please consider joining the study, and if you know anyone else in UK who you think might be interested then please let them know about it.... this is an amazing opportunity to move the science forward for us all!
__________________
Project title, project description, the project objective, the design/methods of the project, characteristics of required participants, main outcome measures, names & status of researchers, name of funding bodies, names of any other involved organisations, starting date of project, expected completion date, contact details and ethical approval information from www.clinicaltrials.gov/ct2/show/study/NCT02249299 are pasted below...
Experimental Medicine in ADHD - Cannabinoids (EMA-C)
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by King's College London
Sponsor:
King's College London
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
ClinicalTrials.gov Identifier:
NCT02249299
First received: September 3, 2014
Last updated: September 23, 2014
Last verified: September 2014
Purpose
Adult patients with ADHD commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their ADHD stimulant medication. The EMA-C study aims to investigate the effects of a cannabis based medication, Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.
This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in improvements in behaviour and cognition above that of the placebo group.
Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Drug: Sativex Oromucosal Spray
Drug: Placebo
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Sativex on Neurocognitive and Behavioural Function in Adults With Attention-deficit/Hyperactivity Disorder; The EMA-C Study (Experimental Medicine in ADHD - Cannabinoids)
Resource links provided by NLM:
MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources
Further study details as provided by King's College London:
Primary Outcome Measures:
Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity' [ Time Frame: 6 weeks (baseline (day 1)-follow-up (day 42)) ] [ Designated as safety issue: No ]
QbTest: The Qb test is a computer administered attention test. An infrared camera monitors patient movement and measures activity; attention and impulsivity are calculated based on the task performance and activity level. The data is processed and compared with a normative group.
Secondary Outcome Measures:
ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42)) ] [ Designated as safety issue: No ]
This will be assessed using the Conners' Adult ADHD Rating Scales (CAARS) and Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADS) combined (investigator rated): Both measure ADHD symptom severity.
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Executive function measured with: The Brief-A.
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Mood measured with: The Affective Lability Scale (ALS-SF)
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Control over thoughts: Cognitive Control Questionnaire
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Brief COPE assesses how participants are coping with stressful life events
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Adult ADHD Quality of Life Scales (AAQoL)
Change in cognitive performance [ Time Frame: 6 weeks (baseline (day 1)-follow-up (day 42)) ] [ Designated as safety issue: No ]
SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention
Estimated Enrollment: 30
Study Start Date: August 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sativex Oromucosal Spray
Participants will titrate onto Sativex during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial
Drug: Sativex Oromucosal Spray
Sativex Oromucosal Spray (GW Pharma Ltd, Salisbury. UK). Each 100 microlitre spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).
Other Name: Sativex
Placebo Comparator: Placebo
Participants will titrate onto the placebo during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial
Drug: Placebo
Eligibility
Ages Eligible for Study: 18 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
The study is open for both men and women aged 18-55 who meet DSM 5 criteria for ADHD (N= 30). Subjects will be either unmedicated or medicated with stimulant medication only and be willing to come of this medication for 1 week before and for the duration of the study. To ensure that this does not disadvantage patients we will only include those on stimulant medication who do not take medication on a regular basis and where short periods of medication are not thought by both the patient and psychiatrist to represent a clinical problem in the overall control of the symptoms and impairments. For example, by including patients who are considering a "stimulant drug holiday", which is a common clinical procedure in ADHD. Subjects must not use other prescription and non-prescription medication or recreational drugs during the study.
Exclusion Criteria:
Exclusion criteria will include autism spectrum disorders and other psychiatric disorders including recurrent major depression, bipolar I disorder, any psychotic disorder and obsessive compulsive disorder and learning difficulties defined as an IQ < 70. Neurological problems and known or suspected history of a drug or alcohol dependence disorder. Subjects who are using or have used cannabis or cannabis based medications in the 30 day period prior to study entry. Concurrent history of renal, hepatic, cardiovascular or convulsive disorders. Females who are pregnant or breastfeeding. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (Note: a male condom should not be used in conjunction with a female condom).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02249299
Contacts
Contact: Emma Williams 02078485367/ 07718669535 emma.2.williams@kcl.ac.uk
Contact: Ruth E Cooper, Msc 02078485401/ 07891173986 ruth.cooper@kcl.ac.uk
Locations
United Kingdom
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London Recruiting
London, United Kingdom, SE5 8AF
Contact: Emma Williams 02078485367/ 07718669535 emma.2.williams@kcl.ac.uk
Contact: Ruth Cooper, Msc 02078485401/ 07891173986 ruth.cooper@kcl.ac.uk
Principal Investigator: Philip Asherson, MD, PhD
Sub-Investigator: Ruth Cooper, Msc
Sub-Investigator: Emma Williams
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
Principal Investigator: Philip Asherson, MD, PhD Institute of Psychiatry, King's College London
More Information
No publications provided
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02249299 History of Changes
Other Study ID Numbers: EMA-C
Study First Received: September 3, 2014
Last Updated: September 23, 2014
Health Authority: United Kingdom: National Health Service
Keywords provided by King's College London:
ADHD,
Cannabis,
Sativex,
Endocannabinoid,
Cognition
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
ClinicalTrials.gov processed this record on March 17, 2015
There is currently a pilot study of treating ADHD using Sativex cannabinoid spray under way at the King's College in London that you can read about at www.clinicaltrials.gov/ct2/show/study/NCT02249299.
They still need to recruit a few adult test subjects!
The best candidates for the study:
1. Have a diagnosis of ADHD
2. Do not use cannabis on a regular basis or are willing to stop for 1 month prior to entering the study
3. Would not be on stimulant medicines or willing to stop for duration of the trial
4. Can visit the centre at King's College in London on 2 occasions at the start of the trial and 6-weeks later
Anyone interested should email Professor Asherson (philip.asherson@kcl.ac.uk).
When this important work is completed we will have broadened our understanding of treating ADHD. The study's significance is monumental as it will lay important groundwork for further research into treating ADHD such as a full-scale clinical trial which allows this promising new medicine to be prescribed for ADHD around the world.
If you fit the criteria please consider joining the study, and if you know anyone else in UK who you think might be interested then please let them know about it.... this is an amazing opportunity to move the science forward for us all!
__________________
Project title, project description, the project objective, the design/methods of the project, characteristics of required participants, main outcome measures, names & status of researchers, name of funding bodies, names of any other involved organisations, starting date of project, expected completion date, contact details and ethical approval information from www.clinicaltrials.gov/ct2/show/study/NCT02249299 are pasted below...
Experimental Medicine in ADHD - Cannabinoids (EMA-C)
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by King's College London
Sponsor:
King's College London
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
ClinicalTrials.gov Identifier:
NCT02249299
First received: September 3, 2014
Last updated: September 23, 2014
Last verified: September 2014
Purpose
Adult patients with ADHD commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their ADHD stimulant medication. The EMA-C study aims to investigate the effects of a cannabis based medication, Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.
This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in improvements in behaviour and cognition above that of the placebo group.
Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Drug: Sativex Oromucosal Spray
Drug: Placebo
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Sativex on Neurocognitive and Behavioural Function in Adults With Attention-deficit/Hyperactivity Disorder; The EMA-C Study (Experimental Medicine in ADHD - Cannabinoids)
Resource links provided by NLM:
MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources
Further study details as provided by King's College London:
Primary Outcome Measures:
Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity' [ Time Frame: 6 weeks (baseline (day 1)-follow-up (day 42)) ] [ Designated as safety issue: No ]
QbTest: The Qb test is a computer administered attention test. An infrared camera monitors patient movement and measures activity; attention and impulsivity are calculated based on the task performance and activity level. The data is processed and compared with a normative group.
Secondary Outcome Measures:
ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42)) ] [ Designated as safety issue: No ]
This will be assessed using the Conners' Adult ADHD Rating Scales (CAARS) and Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADS) combined (investigator rated): Both measure ADHD symptom severity.
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Executive function measured with: The Brief-A.
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Mood measured with: The Affective Lability Scale (ALS-SF)
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Control over thoughts: Cognitive Control Questionnaire
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Brief COPE assesses how participants are coping with stressful life events
Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ] [ Designated as safety issue: No ]
The Adult ADHD Quality of Life Scales (AAQoL)
Change in cognitive performance [ Time Frame: 6 weeks (baseline (day 1)-follow-up (day 42)) ] [ Designated as safety issue: No ]
SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention
Estimated Enrollment: 30
Study Start Date: August 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sativex Oromucosal Spray
Participants will titrate onto Sativex during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial
Drug: Sativex Oromucosal Spray
Sativex Oromucosal Spray (GW Pharma Ltd, Salisbury. UK). Each 100 microlitre spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).
Other Name: Sativex
Placebo Comparator: Placebo
Participants will titrate onto the placebo during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial
Drug: Placebo
Eligibility
Ages Eligible for Study: 18 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
The study is open for both men and women aged 18-55 who meet DSM 5 criteria for ADHD (N= 30). Subjects will be either unmedicated or medicated with stimulant medication only and be willing to come of this medication for 1 week before and for the duration of the study. To ensure that this does not disadvantage patients we will only include those on stimulant medication who do not take medication on a regular basis and where short periods of medication are not thought by both the patient and psychiatrist to represent a clinical problem in the overall control of the symptoms and impairments. For example, by including patients who are considering a "stimulant drug holiday", which is a common clinical procedure in ADHD. Subjects must not use other prescription and non-prescription medication or recreational drugs during the study.
Exclusion Criteria:
Exclusion criteria will include autism spectrum disorders and other psychiatric disorders including recurrent major depression, bipolar I disorder, any psychotic disorder and obsessive compulsive disorder and learning difficulties defined as an IQ < 70. Neurological problems and known or suspected history of a drug or alcohol dependence disorder. Subjects who are using or have used cannabis or cannabis based medications in the 30 day period prior to study entry. Concurrent history of renal, hepatic, cardiovascular or convulsive disorders. Females who are pregnant or breastfeeding. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (Note: a male condom should not be used in conjunction with a female condom).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02249299
Contacts
Contact: Emma Williams 02078485367/ 07718669535 emma.2.williams@kcl.ac.uk
Contact: Ruth E Cooper, Msc 02078485401/ 07891173986 ruth.cooper@kcl.ac.uk
Locations
United Kingdom
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London Recruiting
London, United Kingdom, SE5 8AF
Contact: Emma Williams 02078485367/ 07718669535 emma.2.williams@kcl.ac.uk
Contact: Ruth Cooper, Msc 02078485401/ 07891173986 ruth.cooper@kcl.ac.uk
Principal Investigator: Philip Asherson, MD, PhD
Sub-Investigator: Ruth Cooper, Msc
Sub-Investigator: Emma Williams
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
Principal Investigator: Philip Asherson, MD, PhD Institute of Psychiatry, King's College London
More Information
No publications provided
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02249299 History of Changes
Other Study ID Numbers: EMA-C
Study First Received: September 3, 2014
Last Updated: September 23, 2014
Health Authority: United Kingdom: National Health Service
Keywords provided by King's College London:
ADHD,
Cannabis,
Sativex,
Endocannabinoid,
Cognition
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
ClinicalTrials.gov processed this record on March 17, 2015