CannabisNCT02408640
Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial
A study testing Cannabishjalpen.se in people with Cannabis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this randomized controlled trial is to investigate the effects of a Swedish Internet-based treatment program for individuals from the general population with a regular cannabis use. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cannabis
- What is being tested?
- Cannabishjalpen.se
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteSweden
- Study dates
- 26 Jun 2015to 31 Dec 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >15
- Cannabis use 1 time/week or more often during the past six months.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized controlled trial is to investigate the effects of a Swedish Internet-based treatment program for individuals from the general population with a regular cannabis use.
The primary hypothesis to be tested is that the use of the Internet-based treatment program will be associated with more cannabis-free days in comparison to only access to information about cannabis use and its harmful effects.
Read more
The secondary hypotheses to be tested are:
- That the use of the Internet-based treatment program will be associated with a larger decline in cannabis consumption (frequency and quantity) among individuals with regular cannabis use in comparison to only access to information about Cannabis use and its harmful effects.
- That the use of the Internet-based treatment program will be associated with a larger decline in alcohol consumption, depression and anxiety and increased sense of coherence in comparison to only access to information about Cannabis use and its harmful effects.
- That the proportion of individuals who seek professional help or talk to their relatives or friends about reducing or stopping cannabis use will be greater among those who use the Internet-based treatment program than among those who only have access to information about cannabis use and its harmful effects.
Recruitment procedure and baseline measures Study participants will be recruited through an advertisement on Cannabishjalpen.se. Interested individuals will answer questions about gender, age, country of birth, educational attainment, employment, marital status, living situation, and cannabis use.
The intervention group Individuals randomized to the intervention group will directly after randomization answer questions about alcohol use, use of drugs other than alcohol and cannabis, depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends.
Further, they will fill out a survey on Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will have the opportunity to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to answer questions about their cannabis and alcohol use, as well as about other previously mentioned issues.
The control group Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed).
Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se.
Follow-up procedure Study participants who were randomized to the intervention group will have access to intervention in two months. Three months after recruitment to the study, study participants from both groups will get an automated email invitation to participate in the three-month follow-up. The email will include a personalized link that when clicked on will redirect the participant to follow-up page where they will be asked to once again answer questions about their cannabis and alcohol use, depression and anxiety, seeking professional help for cannabis use as well as the help of family or friends and questions about whether they have used any other internet or telephone services to reduce or quit their cannabis use. The entire follow-up procedure will be completed via the internet.
- Conditions
- Cannabis
- Being tested
- Cannabishjalpen.se
- Keywords
- Internet-Based, Treatment
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabishjalpen.seBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individuals randomized to the intervention group will directly after randomization answer questions about alcohol and drug use (other than alcohol and cannabis), depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends.
Further, they will fill out a survey about Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will be able to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to complete the follow-up. Receives: Behavioral: Cannabishjalpen.se |
| Control group | No intervention | Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed). Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days without cannabis use.
Measured: Past seven days
Secondary outcomes (10)
Grams of cannabis consumed.
Measured: Past three months
Reduction in frequency of cannabis use.
Measured: Past three months
Number of DSM-V criteria for cannabis dependence.
Measured: Past three months
Total score on Cannabis Abuse Screening Test (CAST).
Total score range 0-24 where higher scores indicate worse outcome.
Measured: Past three months
Receiving professional help for cannabis use from relatives or friends.
Measured: Past three months
Receiving help for cannabis use from relatives or friends.
Measured: Past three months
Number of standard (alcohol) drinks.
Measured: Past seven days.
Total score on Sense of coherence Scale.
Total score range13-91, where higher scores indicate better outcome.
Measured: Past three months
Total score on Montgomery Åsberg Depression Rating Scale - Self reported (MADRS-S).
Total score range 0-60 where higher scores indicate worse outcome.
Measured: Past three months
Total score on Generalized Anxiety Disorder Assessment (GAD-7).
Total score range 0-21 where higher scores indicate worse outcome.
Measured: Past three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study start26 Jun 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 CannabisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Sinadinovic, Karolinska Institutet
- Investigators
- Kristina Sinadinovic, PhD, Principal investigator, Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatric Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408640
- Sponsor's protocol ID
- 2014/1374-31/5-1
- Status last verified
- Jul 2019
- First submitted
- 26 Mar 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
Publications
Sinadinovic K, Johansson M, Johansson AS, Lundqvist T, Lindner P, Hermansson U. Guided web-based treatment program for reducing cannabis use: a randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 18;15(1):9. doi: 10.1186/s13722-020-00185-8.
PubMed 32070417
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Treatment for Individuals With Regular Cannabis Use: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02408640
- Acronym / sponsor ID
- 2014/1374-31/5-1
- Conditions
- Cannabis
- Keywords
- Internet-Based, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Apr 2015 (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 aim of this randomized controlled trial is to investigate the effects of a Swedish Internet-based treatment program for individuals from the general population with a regular cannabis use.
The primary hypothesis to be tested is that the use of the Internet-based treatment program will be associated with more cannabis-free days in comparison to only access to information about cannabis use and its harmful effects.
The secondary hypotheses to be tested are:
- That the use of the Internet-based treatment program will be associated with a larger decline in cannabis consumption (frequency and quantity) among individuals with regular cannabis use in comparison to only access to information about Cannabis use and its harmful effects.
- That the use of the Internet-based treatment program will be associated with a larger decline in alcohol consumption, depression and anxiety and increased sense of coherence in comparison to only access to information about Cannabis use and its harmful effects.
- That the proportion of individuals who seek professional help or talk to their relatives or friends about reducing or stopping cannabis use will be greater among those who use the Internet-based treatment program than among those who only have access to information about cannabis use and its harmful effects.
Recruitment procedure and baseline measures Study participants will be recruited through an advertisement on Cannabishjalpen.se. Interested individuals will answer questions about gender, age, country of birth, educational attainment, employment, marital status, living situation, and cannabis use.
The intervention group Individuals randomized to the intervention group will directly after randomization answer questions about alcohol use, use of drugs other than alcohol and cannabis, depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends.
Further, they will fill out a survey on Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will have the opportunity to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to answer questions about their cannabis and alcohol use, as well as about other previously mentioned issues.
The control group Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed).
Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se.
Follow-up procedure Study participants who were randomized to the intervention group will have access to intervention in two months. Three months after recruitment to the study, study participants from both groups will get an automated email invitation to participate in the three-month follow-up. The email will include a personalized link that when clicked on will redirect the participant to follow-up page where they will be asked to once again answer questions about their cannabis and alcohol use, depression and anxiety, seeking professional help for cannabis use as well as the help of family or friends and questions about whether they have used any other internet or telephone services to reduce or quit their cannabis use. The entire follow-up procedure will be completed via the internet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cannabishjalpen.seIndividuals randomized to the intervention group will directly after randomization answer questions about alcohol and drug use (other than alcohol and cannabis), depression, anxiety, a sense of context and whether they during the last 12 months has received professional help to reduce or quit their cannabis use or during the same period have raised this issue with their relatives or friends. Further, they will fill out a survey about Internet-based services for individuals who wish to reduce or quit their cannabis use. The study participants will then be informed that they, within two days, will gain access to an internet based treatment program designed to help them quit their cannabis use and that they through the program will be able to communicate with a therapist. Within the next two days, they will gain access to the internet-based treatment program, they will have access to it for two months and they will be contacted again after three months to complete the follow-up. |
| Control group | No intervention | –Individuals randomized to the control group will undergo exactly the same procedure as the intervention group. The difference is that the control group will be informed that they in about three months will gain access to an internet based treatment program designed to help them quit their cannabis use (i.e. when the data collection for follow-up is completed). Otherwise, participants in both groups will have the opportunity to use factual information that is available to everyone on Cannabishjalpen.se. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age >15
- Cannabis use 1 time/week or more often during the past six months.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cannabishjalpen.se | Behavioural | Intervention group |
Primary outcome
Number of days without cannabis use.
Time frame: Past seven days
10 secondary outcomes
Grams of cannabis consumed.
Time frame: Past three months
Reduction in frequency of cannabis use.
Time frame: Past three months
Number of DSM-V criteria for cannabis dependence.
Time frame: Past three months
Total score on Cannabis Abuse Screening Test (CAST).
Time frame: Past three months
Receiving professional help for cannabis use from relatives or friends.
Time frame: Past three months
Receiving help for cannabis use from relatives or friends.
Time frame: Past three months
Number of standard (alcohol) drinks.
Time frame: Past seven days.
Total score on Sense of coherence Scale.
Time frame: Past three months
Total score on Montgomery Åsberg Depression Rating Scale - Self reported (MADRS-S).
Time frame: Past three months
Total score on Generalized Anxiety Disorder Assessment (GAD-7).
Time frame: Past three months
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 29 Jul 2019.
- Derived from this study: PubMed 32070417Sinadinovic K, Johansson M, Johansson AS, Lundqvist T, Lindner P, Hermansson U. Guided web-based treatment program for reducing cannabis use: a randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 18;15(1):9. doi: 10.1186/s13722-020-00185-8.
- Cannabishjalpen.seLink 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.
Kristina Sinadinovic, PhD principal investigator
Karolinska Institutet, Department of Clinical Neuroscience, Center for Psychiatric Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabishjalpen.se in people with Cannabis, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 1 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 29 Jul 2019. 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 Sweden. 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.
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?
Number of days without cannabis use. (time frame: Past seven days). 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 NCT02408640, 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 29 Jul 2019.